: Medical Devices : Health Industry Washington Watch

Posted on January 27, 2012 by Lisa Baird

Overview and Analysis of the Proposed Federal Sunshine Regulations

This post was written by Elizabeth B. Carder-Thompson, Katie C. Pawlitz, Nancy E. Bonifant and Debra A. McCurdy.

On December 19, 2011, the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule (the “Proposed Rule”) related to section 6002 of the Affordable Care Act, commonly referred to as the “Physician Payment Sunshine Act” (so referenced herein, or as the “Act”). The Physician Payment Sunshine Act requires applicable manufacturers of drugs, devices, biologicals, or medical supplies covered under Medicare, Medicaid, or CHIP to report annually to the Secretary of the Department of Health and Human Services (“Secretary”) certain payments or other transfers of value to physicians and teaching hospitals. Additionally, applicable manufacturers and applicable group purchasing organizations (“GPOs”) must report certain information regarding the ownership or investment interests in them that are held by physicians or their immediate family members.

The Proposed Rule comes more than two months after CMS’s statutory deadline of October 1, 2011. CMS proposes an expansive reading of its statutory authority, arguably extending reporting requirements to manufacturers and payments not contemplated by Congress. Moreover, while offering some much-needed clarification regarding certain tracking and reporting obligations under the Act, it leaves many questions unanswered. Indeed, CMS solicits comments on almost every aspect of the Proposed Rule – 60 topic areas in all. Accordingly, significant ambiguity still remains in terms of compliance with certain aspects of the Act. Comments to the Proposed Rule are due no later than 5 p.m. ET February 17, 2012.

This Client Alert outlines the guidance and proposals included in the Proposed Rule. As further discussed in this Alert, CMS has delayed implementation of tracking requirements under the Physician Payment Sunshine Act, but applicable manufacturers and GPOs still are advised to continue to prepare for implementation of the Act, potentially occurring during this calendar year 2012. Applicable manufacturers and applicable GPOs may do so by taking steps to ensure that tracking and reporting systems conform to the requirements of the Act and the Proposed Rule, to the extent clarity is currently available, and by closely monitoring future CMS guidance in this area.

To read the full Alert, click here.

Tags: Centers for Medicare & Medicaid Services Developments, Centers for Medicare and Medicaid Services Developments, Department of Health & Human Services (HHS), Drugs, Group Purchasing Organizations (GPOs), Medical Devices, Patient Protection and Affordable Care Act (PPACA), Physician Ownership, Physician Payment Sunshine Act, Sunshine Act

Posted on January 25, 2012 by Debra A. McCurdy

E&C Health Subcommittee Plans FDA User Fee Hearings in February

The House Energy and Commerce Health Subcommittee has announced a series of hearings on FDA user fees for prescription drugs, generic drugs, biosimilar drugs, and medical devices. The hearing schedule is as follows: a February 1, 2012 hearing will address reauthorization of the Prescription Drug User Fee Act; on February 7, a Subcommittee hearing will focus on the new Generic Drug User Fee proposal and Biosimilar User Fee proposal; and on February 15, the Subcommittee will hold a hearing on reauthorization of the Medical Device User Fee Act.

Tags: Health Care Industry Events, Legislative Developments, Biosimilars, Drugs, FDA, Hearings and Markups, Medical Devices, Patient Protection and Affordable Care Act (PPACA), generic drugs

Posted on January 23, 2012 by Debra A. McCurdy

E&C Health Subcommittee Plans FDA User Fee Hearings in February

The House Energy and Commerce Health Subcommittee has announced a series of hearings on FDA user fees for prescription drugs, generic drugs, biosimilar drugs, and medical devices. The hearing schedule is as follows:

A February 1, 2012 hearing will address reauthorization of the Prescription Drug User Fee Act;
A February 7 hearing will focus on the new Generic Drug User Fee proposal and Biosimilar User Fee proposal; and
A February 15 hearing will examine reauthorization of the Medical Device User Fee Act.

Tags: Health Care Industry Events, Biosimilars, Drugs, FDA, Hearings and Markups, Medical Devices, generic drugs

Posted on January 5, 2012 by Debra A. McCurdy

GAO Report on Pediatric Medical Devices

The Government Accountability Office (GAO) has issued a report entitled “Pediatric Medical Devices: Provisions Support Development, but Better Data Needed for Required Reporting.” This report: (1) describes barriers to developing pediatric devices, (2) describes how pediatric device consortia have contributed to the development of pediatric devices, and (3) examines FDA data on the number of pediatric devices approved since FDAAA was enacted. The GAO found that while FDA created an electronic flag in its internal tracking system to identify devices labeled for use in pediatric patients, FDA has not consistently used this flag and therefore lacks reliable and timely information needed for reporting. The GAO recommends that FDA collect reliable information to report data on pediatric medical devices by consistently using its existing pediatric electronic flag in its tracking system or otherwise developing internal controls. HHS concurred with GAO’s recommendations.

Tags: Other GAO Developments, FDA, Fraud and Abuse, Medical Devices

Posted on December 29, 2011 by Debra A. McCurdy

FDA Issues Draft Guidance Regarding Evaluation of Sex Differences in Medical Device Clinical Studies

This post was written by Erin Janssen.

The FDA recently issued draft guidance entitled “Evaluation of Sex Differences in Medical Device Clinical Studies,” which indicates FDA's current view of the study and evaluation of sex-specific differences in medical device clinical trials to support marketing submissions and post-approval study. In particular, the focus is on addressing potential differences in study design, conduct, outcomes, and interpretation that should be considered to ensure sex-specific issues are adequately addressed. The intent of the guidance is to improve the quality and consistency of available data regarding the performance of medical devices in both sexes, to encourage proportional enrollment of women representative of disease demographics and provide guidance on reporting of sex-specific information. Although comments can be submitted at any time, FDA is requesting that interested parties submit their comments by March 19, 2012.

Tags: Other FDA Developments, Clinical trials, FDA, Medical Devices

Posted on December 29, 2011 by Debra A. McCurdy

FDA Provides Draft Guidance on Evaluating Substantial Equivalence in Premarket Notifications

This post was written by Erin Janssen.

On December 27, 2011, FDA released draft guidance entitled “Draft Guidance for Industry and Food and Drug Administration Staff; The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].” The draft guidance is designed to provide a contemporary perspective on FDA reviews of premarket notification (510(k)) submissions. The guidance addresses the major aspects of the 510(k) decision making process and updates FDA’s policies with respect to the Special and Abbreviated 510(k) programs. The intent of the draft guidance is to identify, explain, and clarify each of the critical decision points in the decision-making process FDA uses to determine substantial equivalence to enhance the predictability, consistency, and transparency of the 510(k) program by describing in greater detail the regulatory framework, policies, and practices underlying FDA’s 510(k) review. FDA is requesting comments on the guidance by April 26, 2012.

Tags: Other FDA Developments, FDA, Medical Devices

Posted on December 29, 2011 by Debra A. McCurdy

FDA Guidance Regarding CDRH Appeals Process

This post was written by Erin Janssen.

Draft guidance released by FDA on December 27, 2011, “Center for Devices and Radiological Health (CDRH) Appeals Processes,” describes the processes available to outside stakeholders to request additional review of decisions and actions by CDRH employees, provides general information about each process, and offers guidance on how to submit related requests to CDRH and FDA. FDA requests comments on the document by April 26, 2012.

Tags: Other FDA Developments, FDA, Medical Devices

Posted on December 14, 2011 by Debra A. McCurdy

CMS Releases Long-Awaited Physician Payments Sunshine Act Proposed Rule

This post was written by Elizabeth B. Carder-Thompson, Katie C. Pawlitz and Debra A. McCurdy.

The Centers for Medicare & Medicaid Services (“CMS”) released today a proposed rule implementing the physician payment transparency provisions of the Patient Protection and Affordable Care Act (Section 6002), commonly referred to as the "Physician Payments Sunshine Act." Among other things, the Act requires drug, device, biological or medical supply manufacturers to report payments or other transfers of value to physicians and other covered recipients. In addition, the Act requires manufacturers and group purchasing organizations (GPOs) to report certain information regarding ownership or investment interests held by a physician in the manufacturer or GPO.

The official version of the proposed rule, titled “Transparency Reports and Reporting of Physician Ownership of Investment Interests” (the “Proposed Rule”), will be published in the Federal Register on December 19, 2011. Comments on the Proposed Rule are due no later than 5:00 PM EST on February 17, 2011.

Although released later than the statutory deadline for the regulations (October 1, 2011), upon initial review, the Proposed Rule appears to provide important guidance to manufacturers regarding several aspects of the Physician Payments Sunshine Act. Notably, CMS has announced that manufacturers and GPOs will not be required to collect required information until after the final rule is published (rather than the statutory January 1, 2012 deadline). CMS anticipates publishing the final rule “as soon as possible” in 2012.

We are in the process of conducting a full review of the Proposed Rule and will release shortly a Client Alert providing a detailed analysis of the proposal. In the meantime, please contact Elizabeth Carder-Thompson (202-414-9213 or ecarder@reedsmith.com), Katie C. Pawlitz (202-414-9233 or kpawlitz@reedsmith.com), or any other member of the Reed Smith Health Care Group with whom you work, if you would like additional information or if you have any questions.

Tags: Centers for Medicare & Medicaid Services Developments, Centers for Medicare and Medicaid Services Developments, Department of Health & Human Services (HHS), Drugs, Group Purchasing Organizations (GPOs), Medical Devices, Patient Protection and Affordable Care Act (PPACA), Physician Ownership, Physician Payment Sunshine Act, Sunshine Act

Posted on December 13, 2011 by Debra A. McCurdy

FDA Draft Guidance on Artificial Pancreas Device Systems, Hepatitis B Screening of Blood/Blood Components

This post was written by Erin Janssen.

The FDA has issued draft guidance on “The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems.” The document provides industry and FDA staff with guidelines for developing premarket submissions for artificial pancreas device systems, in particular, the Control-to-Range and Control-to-Target device systems. Although comments on the guidance can be submitted at any time, FDA is requesting that interested parties submit their comments by March 5, 2012. Separately, the FDA has released draft guidance to the industry, particularly blood establishments that collect Whole Blood and blood components for transfusion or for further manufacture (including recovered plasma, Source Plasma, and Source Leukocytes) on the use of FDA-licensed nucleic acid tests (NAT) to screen blood donors for hepatitis B virus (HBV) deoxyribonucleic acid. FDA also provides recommendations for product testing and disposition, donor management, methods for donor requalification, and product labeling. The guidance explains that FDA considers the use of an FDA-licensed HBV NAT to be necessary to reduce adequately and appropriately the risk of transmission of HBV. Comments are due January 27, 2012.

Tags: Other FDA Developments, Other HHS Developments, FDA, Medical Devices

Posted on November 30, 2011 by Debra A. McCurdy

ACA "Physician Payment Sunshine Act" Rule at OMB

The Centers for Medicare & Medicaid Services (CMS) has sent to the White House Office of Management and Budget (OMB) its long-awaited proposed rule to implement the Transparency Reports and Reporting of Physician Ownership of Investment Interests (also called the Physician Payment Sunshine Act) provisions of the ACA. These provisions are intended to encourage greater transparency in the relationships between drug and device companies and physicians by (among other things) requiring covered drug, device, biological or medical supply manufacturers that provide a payment or other transfer of value to a “covered recipient” – a physician or a teaching hospital – to submit detailed reports to the HHS Secretary. In addition, the provision requires certain manufacturers and group purchasing organizations (GPOs) to report to the Secretary certain information regarding ownership or investment interests held by a physician in the manufacturer or GPO. The text of the rule is not available at this stage, but the rule could reach the Federal Register in the near future. As noted in a separate posting, the Senate Aging Committee has scheduled a December 15 hearing on this issue.

Tags: Centers for Medicare & Medicaid Services Developments, Department of Health & Human Services, Drugs, Group Purchasing Organizations (GPOs), Medical Devices, Patient Protection and Affordable Care Act (PPACA), Physician Ownership, Physician Payment Sunshine Act, Sunshine Act

Posted on November 29, 2011 by Debra A. McCurdy

Congressional Health Policy Hearings

The Senate Health, Education, Labor, and Pensions Committee recently held a hearing on “Medical Devices: Protecting Patients and Promoting Innovation” (a Reed Smith write-up of the hearing is available here). In addition, a recent House Ways and Means Oversight Subcommittee hearing focused on the ACA’s small business health insurance tax credit. Two hearings are scheduled for November 30: a Senate Special Committee on Aging hearing entitled “Overprescribed: The Human and Taxpayers' Costs of Antipsychotics in Nursing Homes” and a House Oversight and Government Reform Health Care Subcommittee hearing on “Drug Shortage Crisis: Lives Are In The Balance.” The Senate Judiciary Antitrust Subcommittee also is holding a hearing on December 6 to examine the proposed Express Scripts/Medco merger, and the Senate Aging Committee is holding a hearing December 15 entitled “Parting the Clouds: Implementing the Physician Payment Sunshine Act” (this hearing originally was scheduled for Dec. 8).

Tags: Legislative Developments, Drugs, Hearings and Markups, Insurance, Medical Devices, Nursing Homes, Patient Protection and Affordable Care Act (PPACA), Skilled Nursing Facilities, tax

Posted on November 29, 2011 by Debra A. McCurdy

FY 2013 IPPS New Technology Payment Town Hall Meeting (Feb. 14, 2012)

CMS has announced a February 14, 2012 town hall meeting to discuss FY 2013 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS). The meeting provides an opportunity for interested parties to present recommendations and data regarding whether FY 2013 new medical services and technologies applications meet CMS’s substantial clinical improvement criterion.

Tags: Health Care Industry Events, Hospital, Inpatient hospital, Medical Devices

Posted on November 11, 2011 by Debra A. McCurdy

Congressional Health Policy Hearings & Markups

A number of Congressional committees have held hearings recently on health policy issues, including the following:

A House Energy and Commerce Health hearing entitled “Do New Health Law Mandates Threaten Conscience Rights and Access to Care?”;
A Senate Judiciary Subcommittee on Privacy, Technology and the Law hearing on “Your Health and Your Privacy: Protecting Health Information in a Digital World”;
A Senate Special Committee on Aging hearing on Assisted Living Quality and Oversight; and
A Senate Health, Education, Labor and Pensions (HELP) Committee hearing on "Improving Quality, Lowering Costs: The Role of Health Care Delivery System Reform.”

A number of additional hearings and markups have been scheduled, including:

A November 15 Senate HELP Committee hearing on “Medical Devices: Protecting Patients and Promoting Innovation”;
A November 15 House Ways and Means Oversight Subcommittee hearing on the ACA’s small business health insurance tax credit;
A December 6, 2011 Senate Judiciary Antitrust Subcommittee hearing on the proposed Express Scripts/Medco merger; and
An Energy and Commerce Health Subcommittee markup of H.R. 1173, the "Fiscal Responsibility and Retirement Security Act of 2011," which would repeal the ACA’s Community Living Assistance Services and Supports (CLASS) program.

Tags: Legislative Developments, Drugs, HIPAA, Hearings and Markups, Medical Devices, Patient Protection and Affordable Care Act (PPACA), Privacy, tax

Posted on October 28, 2011 by Debra A. McCurdy

Correction Notice on CMS/FDA Parallel Review Pilot Program

As previously reported, CMS and the FDA published a notice October 11, 2011 soliciting nominations from sponsors of medical devices to participate in a parallel review pilot program. CMS has updated certain information in the October 11 notice, including correcting the web site and email address for more information on parallel reviews.

Tags: Centers for Medicare & Medicaid Services Developments, FDA, Medical Devices

Posted on October 14, 2011 by Debra A. McCurdy

FDA Issues Draft Guidance to Clarify De Novo Classification Process

This post was written by Erin Janssen and Areta Kupchyk.

On October 3, 2011, the FDA released draft guidance entitled “De Novo Classification Process (Evaluation of Automatic Class III Designation).” The document is intended to provide guidance to FDA staff and industry on the process for the submission and review of petitions submitted under the Federal Food, Drug, and Cosmetic Act, also known as the de novo classification process. The draft guidance contains updated recommendations designed to foster efficient interaction with FDA, including what information to submit, when seeking a path to market via the de novo process. It also describes a mechanism to provide greater clarity about the suitability of a device for de novo review, and timely input on the type of data necessary to support de novo classification of an eligible device. Comments on the guidance should be submitted by December 2, 2011.

Tags: Other FDA Developments, Other HHS Developments, FDA, Medical Devices

Posted on October 12, 2011 by Debra A. McCurdy

CMS and FDA Publish Parallel Review Pilot Program Notice

On October 7, 2011, the Centers for Medicare & Medicaid Services and the Food and Drug Administration announced they are soliciting nominations from sponsors of medical devices to participate in a parallel review pilot program. The Agencies officially published a Federal Register notice announcing the program October 11, 2011 (the "Notice"), with an effective date of November 10, 2011, although the agencies began accepting nomination submissions October 7. Notably, drugs and biological manufacturers are not included in this pilot program, although the agencies state that they intend to use their experience with the medical device pilot program to expand the program to include drugs and biological products in the future. The Notice outlines the procedures for participation in the pilot program, emphasizes the voluntary nature of the pilot program, discusses the appropriate candidates for the pilot program, and conveys the "guiding principles" the agencies plan to follow in implementing the pilot program. The agencies intend to run the pilot program for two years, with the possibility of an extension beyond the two-year program or termination prior to the end of the two-year program. Because of constrained resources, the agencies plan to accept only three to five nominations for parallel review per year. Reed Smith's Alert summarizes the Notice and discusses potential implications for manufacturers that may be considering participation in the pilot program.

Tags: Regulatory Developments, Centers for Medicare & Medicaid Services Developments, Department of Health & Human Services, Food & Drug Administration Developments, Medical Devices, Premarket Approval, Regulatory Compliance

Posted on September 29, 2011 by Debra A. McCurdy

CMS Seeks Comments on Potential Medicare Coverage Determination Topics

CMS is inviting public comments on potential topics for Medicare national coverage determinations (NCDs) “to use Medicare coverage to help align program incentives with the best available clinical evidence.” While CMS issued a list of potential NCDs in 2008, the agency notes that there have been “significant developments in new technologies and changes to CMS authorities under statute” since that time. CMS now seeks input on items and services that may be inappropriately used (including underused, overused, or misused) or that provide minimal benefit. Such items and services could include surgical procedures, diagnostic tests or procedures, imaging or radiology services, lab tests, durable medical equipment, treatments for diseases, or procedures such as orthopedic or eye procedures. CMS will accept comments until November 27, 2011. After the agency reviews comments based on relevance to the NCD authority and potential impact on the Medicare program, a revised list will be released.

Tags: Other CMS Developments, Other HHS Developments, Coverage, DMEPOS, Medical Devices, Radiology

Posted on September 29, 2011 by Debra A. McCurdy

Congressional Hearings Examine Variety of Health Industry Issues

Recent Congressional hearings focusing on health policy issues include:

House Ways and Means Committee hearings on expiring Medicare provider payment provisions and the impact of health sector mergers and acquisitions on private health insurance costs;
A Senate Health, Education, Labor and Pensions Committee hearing on "Securing the Pharmaceutical Supply Chain";
A House Judiciary Committee hearing on “The Proposed Merger betweenExpress Scripts and Medco”;
A House Oversight and Government Reform Committee hearing entitled "Examining Abuses of Medicaid Eligibility Rules";
A Senate Finance Committee hearing on "Dually-Eligible Beneficiaries: Improving Care While Lowering Costs"; and
House Energy and Commerce Health Subcommittee hearings entitled "Cutting the Red Tape: Saving Jobs from PPACA's Harmful Regulations," “The Increase in Drug Shortages,” and a field hearing in La Jolla, CA on the “Impact of Medical Device and Drug Regulation on Innovation, Jobs and Patients: A Local Perspective.”

In addition, on October 4, the Senate Homeland Security and Governmental Affairs Subcommittee on Federal Financial Management has scheduled a hearing on "Costs of Prescription Drug Abuse in the Medicare Part D Program."

Tags: Legislative Developments, Drug Safety, Drugs, Hearings and Markups, Medicaid, Medical Devices, Medicare, Patient Protection and Affordable Care Act (PPACA), dual eligibles

Posted on September 22, 2011 by Debra A. McCurdy

Upcoming House Hearings on Drug Shortages, Device/Drug Regulations

The Energy and Commerce Health Subcommittee has scheduled a September 23, 2011 hearing on “The Increase in Drug Shortages,” and a September 26 field hearing in La Jolla, CA on the “Impact of Medical Device and Drug Regulation on Innovation, Jobs and Patients: A Local Perspective.”

Tags: Legislative Developments, Drug Safety, Drugs, Hearings and Markups, Medical Devices, Regulatory review

Posted on September 1, 2011 by Debra A. McCurdy

HHS Issues Final Plan to Reduce Regulatory Burdens

On August 22, 2011, HHS released its “Plan for Retrospective Review of Existing Rules.” The plan was developed in compliance with Executive Order 13563, which directed agencies to design cost effective, evidence-based regulations that are compatible with economic growth, job creation, and competitiveness, and which rely on the best, most innovative, and least burdensome tools to achieve regulatory ends. HHS’s plan identifies a preliminary list of regulations that are appropriate candidates for review over the next two years and establishes an ongoing process of retrospective review of existing regulations to determine whether any should be streamlined, expanded, or repealed (which could necessitate new rulemaking). For instance, based on a retrospective review of current regulations, CMS plans to issue a proposed rule in September 2011 that would revise obsolete or burdensome hospital conditions of participation requirementsl the Administration estimates the changes may save up to $3 billion over five years. HHS also highlights Medicare regulatory reviews involving: quality reporting, Medicare appeals, and Medicare payment policy revisions designed to reduce documentation burdens and clarify requirements. The listing for Food and Drug Administration (FDA) regulatory review items includes revisions to the FDA's bar code rule, good manufacturing practice regulations for drugs, and medical device adverse event report requirements.

Tags: Department of Health & Human Services, FDA, Hospital, Medical Devices, Regulatory review

Posted on September 1, 2011 by Debra A. McCurdy

FDA Issues Draft Guidance Proposing Risk Based Approach to Oversight of Clinical Investigations

This post was written by Erin Janssen.

On August 29, 2011, the FDA released draft guidance entitled “Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring.” FDA published the draft guidance to assist sponsors of clinical investigations in developing risk-based monitoring strategies and plans for clinical investigations of human drug and biological products, medical devices, and combinations thereof. The guidance is intended to make clear that sponsors can use a variety of approaches to meet their monitoring responsibilities during clinical investigations. The guidance describes a risk-based approach to monitoring that focuses on critical study parameters and relies on a combination of monitoring activities to effectively oversee a study. For example, the guidance encourages greater use of centralized monitoring methods where appropriate. The guidance also makes recommendations about how to develop monitoring plans and document monitoring activities. While interested parties may submit comments on the guidance at any time, the agency is requesting comments by November 28, 2011.

Tags: Other FDA Developments, Other HHS Developments, Clinical trials, Drugs, Medical Devices

Posted on August 16, 2011 by Debra A. McCurdy

FDA Issues Draft Guidance Regarding Design of Pivotal Clinical Investigations for Medical Devices

This post was written by Erin Janssen.

The Food and Drug Administration (FDA) issued draft guidance on August 15, 2011 to help researchers and manufacturers design better quality clinical studies in support of premarket approval applications for certain medical devices. Although the public can comment on the draft guidance at any time, FDA has requested that interested parties submit their comments by November 14, 2011. FDA has previously articulated policies related to design of studies intended to support specific device types, and a general policy of tailoring the evidentiary burden to the regulatory requirement, but the FDA has not previously attempted to describe the different clinical study designs that may be appropriate to support a device premarket submission, or to define how a sponsor should decide which pivotal clinical study design should be used to support a submission for a particular device. The draft guidance describes different study design principles relevant to the development of medical device clinical studies that can be used to fulfill premarket clinical data requirements. The guidance applies to therapeutic and aesthetic devices and diagnostic devices. While the guidance also includes principles that are applicable to device-specific issues for combination products defined under 21 CFR Part 3 (e.g., device-drug products; device-biologic products), drug-specific or biologic-specific issues that may also be relevant for a combination product are not described. In addition, the document is not intended to provide a comprehensive tutorial on the best clinical and statistical practices for investigational medical device studies.

Tags: Other FDA Developments, Clinical trials, Medical Devices

Posted on July 28, 2011 by Debra A. McCurdy

FDA Issues Draft Guidance Regarding When to Submit a 510(k) for a Change to an Existing Device; Guidance Follows 510(k) Working Group Recommendations

This post was written by Kevin M. Madagan.

On July 27, 2011, the Food and Drug Administration (“FDA” or “Agency”) released a draft guidance document for manufacturers regarding when to submit a premarket notification submission (510(k)) for changes or modifications made to a previously cleared medical device. When final, this guidance will supersede a guidance document that FDA issued in 1997 (Deciding When to Submit a 510(k) for a Change to an Existing Device), and serve as an important development in FDA’s continuing effort to strengthen the Agency’s 510(k) program.

As background, under current FDA regulations, a manufacturer is not required to submit a new 510(k) for a device modification unless the modification “could significantly affect the safety or effectiveness of the device” or there has been a “major change or modification to the intended use of the device.” 21 C.F.R. § 807.81(a)(3). These regulations allow manufacturers to make incremental or so-called “minor” modifications to devices on the market that are immaterial to safety and effectiveness, without undue regulatory burden.

FDA’s new draft guidance – 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device – reflects the Agency’s current thinking on device changes and emphasizes the most important factors in determining whether to submit a 510(k) for a device modification. Among other things, the draft guidance includes a new section for manufacturing process changes, discusses nanotechnology, contains new questions to help guide manufacturers, and is full of detailed examples. The draft guidance highlights common changes to devices that would require a new 510(k), and changes that could simply be documented without the submission of a 510(k) in accordance with a manufacturer’s existing Quality System without prompting the need for a new 510(k) submission.

The draft guidance also addresses numerous concerns raised in August 2010 by FDA’s 510(k) Working Group, which was convened in September 2009 as part of a two-pronged, comprehensive assessment of the 510(k) process. The Working Group expressed concerns about faulty beliefs and assumptions held by the industry about device modifications, including, among other things, concerns that:

Manufacturers were misinterpreting federal regulation to mean that a new 510(k) is only necessary if a modification definitively does affect safety and/or effectiveness. In actuality, the regulation, 21 C.F.R. § 807.81(a)(3), requires a new 510(k) for any change or modification that “could significantly affect” either the safety or the effectiveness of a device. Whether a change could significantly affect the safety or effectiveness of a device is one of the key issues the new draft guidance tries to address.
Manufacturers were misinterpreting the regulation to mean that a new 510(k) is only necessary if a modification could significantly negatively affect safety and/or effectiveness. The Working Group was concerned that manufacturers did not appear to appreciate that device changes intended as improvements to a device’s safety or effectiveness could also significantly affect safety or effectiveness and require a new 510(k).
Manufacturers did not understand what types of manufacturing process changes might warrant the submission of a new 510(k).

Although we are still assessing the contents and implications of the document, FDA’s new draft guidance appears to be a step in the right direction, and one that, if it becomes a final guidance document, would help to improve FDA’s 510(k) program – a program that has been slow to adapt to the evolving complexity of medical devices.

Please note that Reed Smith attorneys are currently preparing a comprehensive analysis of the new draft guidance. Our analysis will be posted on this blog and the Reed Smith website within the next few days. FDA is accepting electronic or written comments on the draft guidance until October 25, 2011 (identified by Docket No. FDA-2011-D-0453).

Tags: Other FDA Developments, Other HHS Developments, FDA, Medical Devices

Posted on July 26, 2011 by Debra A. McCurdy

FDA Issues Draft Guidance Regarding Mobile Medical Applications

This post was written by Erin Janssen.

On July 19, 2011 the FDA released a draft guidance document regarding the use and oversight of mobile medical applications. FDA is seeking input on its proposed oversight approach for certain mobile applications specific to medicine or health care called mobile medical applications ("apps") that are designed for use on smartphones and other mobile computing devices. This approach encourages the development of new apps, focuses only on a select group of applications and will not regulate the sale or general consumer use of smartphones or tablets. The agency’s draft guidance defines a small subset of mobile medical apps that impact or may impact the performance or functionality of currently regulated medical devices to be regulated. This subset includes mobile medical apps that are used as an accessory to medical device already regulated by the FDA (e.g., an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet) or transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices (e.g., an application that turns a smartphone into an ECG machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack). A notice regarding the draft guidance was published in the Federal Register on July 21, 2011; comments on the guidance are due October 19, 2011.

Tags: Other FDA Developments, Other HHS Developments, FDA, Medical Devices

Posted on July 26, 2011 by Debra A. McCurdy

FDA Issues Guidance and Final Rule Regarding Focused Ultrasound Stimulators for Aesthetic Use

This post was written by Erin Janssen.

On July 20, 2011, the FDA issued both a final rule and a guidance document regarding the classification of Focused Ultrasound Stimulators for Aesthetic Use as Class II Special Control devices. The final rule indicated that the special control(s) that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use." Adherence to the recommendations described in the guidance document, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of focused ultrasound stimulator system for aesthetic use classified under 878.4590 (21 CFR Part 878). In order to be classified as a class II device under 878.4590, an ultrasound stimulator for aesthetic use must comply with the requirements of special controls; a manufacturer must address the issues requiring special controls as identified in the guidance, either by following the recommendations in the guidance document or by some other means that provides equivalent assurances of safety and effectiveness. While the rule is final, comments on the guidance document may be submitted at any time to FDA.

Tags: Other FDA Developments, Department of Health & Human Services, FDA, Food & Drug Administration Developments, Medical Devices

Posted on July 18, 2011 by Debra A. McCurdy

FDA Issues Draft Guidance Related to IVD Companion Diagnostic Devices

This post was written by Erin A. Janssen and Areta L. Kupchyk.

On July 14, 2011, the FDA issued draft guidance entitled “In Vitro Companion Diagnostic Devices.” The guidance is intended to assist sponsors planning to develop a therapeutic product that depends on the use of an in vitro companion diagnostic device for its safe and effective use or an in vitro diagnostic device that is intended for use with a corresponding therapeutic product and included in the instructions for use in the labeling of those products. The guidance defines in vitro companion diagnostic devices; explains the need for FDA oversight of companion diagnostic devices; clarifies that, in most circumstances, if use of a companion diagnostic device is essential for the safe and effective use of a therapeutic product, the diagnostic device and therapeutic product should be approved or cleared contemporaneously by FDA for the use indicated in the therapeutic product labeling; provides guidance for industry and FDA staff on possible premarket regulatory pathways and FDA’s regulatory enforcement policy; and describes certain statutory and regulatory approval requirements relevant to therapeutic product labeling that stipulate concomitant use of a companion diagnostic device to ensure safety and effectiveness of the therapeutic product. Comments on the guidance are due by September 12, 2011.

Tags: Department of Health & Human Services, FDA, Food & Drug Administration Developments, Medical Devices

Posted on July 18, 2011 by Debra A. McCurdy

FDA Proposed Rule Would Eliminate Certain Drug Pedigree Requirements

This post was written by Erin A. Janssen and Areta L. Kupchyk.

On July 14, 2011, the Food and Drug Administration (FDA) published a proposed rule to remove a section of the Prescription Drug Marketing Act (PDMA) regulations to permit wholesale distributors to document the chain of custody (also known as the "pedigree") of prescription drug products only back to the last "authorized distributor" instead of all the way back to the manufacturer. The PDMA requirements as currently written require that prior to the completion of any wholesale distribution of a prescription drug, an unauthorized distributor must provide to the purchaser “a statement identifying each prior sale, purchase, or trade of such drug,” starting with the manufacturer, and that the identifying statement (i.e., “pedigree”) must include certain information about the drug and each prior sale, purchase, or trade. FDA indicated that this action is being taken in response to longstanding issues, including an injunction currently in effect handed down by the District Court for the Eastern District of New York, regarding the application of and compliance with this requirement. FDA also announced in the proposed rule that it intends to exercise enforcement discretion while the rulemaking is pending as long as the pedigree identifies the names and addresses of the last authorized distributor of record that handled the drug and the associated dates of transactions involving that last authorized distributor of record and the drug, as well as the names and addresses of all subsequent unauthorized distributors that handled the drug and the corresponding dates of those transactions. Comments on the proposed rule are due to the agency on or before September 12, 2011.

Tags: Department of Health & Human Services, FDA, Food & Drug Administration Developments, Medical Devices

Posted on June 28, 2011 by Debra A. McCurdy

GAO Issues Report on FDA Oversight of Medical Device Recalls.

This post was written by Erin A. Janssen.

On June 14, 2011, the GAO released a report entitled "Medical Devices: FDA Should Enhance Its Oversight of Recalls." The report identifies: (1) the numbers and characteristics of medical device recalls and the FDA’s use of this information to aid its oversight, and (2) the extent to which the recall process ensures the effective implementation and termination of the highest-risk recalls. GAO interviewed FDA officials and examined information on medical device recalls initiated and reported from 2005 through 2009, and reviewed FDA's documentation for a sample of 53 (40%) of class I recalls initiated during this period. From 2005 through 2009, the GAO found that firms initiated 3,510 medical device recalls, or an average of 700 per year. FDA classified the vast majority--nearly 83%--as class II, meaning use of these recalled devices carried a moderate health risk, or that the probability of serious adverse health consequences was remote. Just over 40% of the recalls involved cardiovascular, radiological, or orthopedic devices. The GAO found that the FDA has not routinely analyzed recall data to determine whether there are systemic problems underlying trends in device recalls and therefore is missing an opportunity to use recall data to proactively identify and address the risks presented by unsafe devices. The GAO also found that gaps in the medical device recall process limited firms' and FDA's abilities to ensure that the highest-risk recalls were implemented in an effective and timely manner. For many high-risk recalls, firms faced challenges, such as locating specific devices or device users, and thus could not correct or remove all devices and that FDA's procedures for overseeing recalls are unclear. As a result, FDA officials examining similar situations sometimes reached opposite conclusions on whether recalls were effective. FDA had also not established criteria, based on the nature or type of devices, for assessing whether firms corrected or removed a sufficient number of recalled devices. The GAO report indicates that FDA's decisions to terminate completed recalls--that is, assess whether firms had taken sufficient actions to prevent a recurrence of the problems that led to the recalls--were frequently not made within its prescribed time frames. Finally, FDA did not document its justification for terminating recalls. The report concluded that if unaddressed by FDA, the combined effect of these gaps may increase the risk that unsafe medical devices could remain on the market. To enhance FDA’s oversight of medical device recalls, and in particular, those medical device recalls that pose the highest risk, the GAO recommended that FDA take the following four actions: (i) creation of a program to routinely and systematically assess medical device recall information, which should be designed, at a minimum, to identify trends in the numbers and types of recalls, the devices most frequently being recalled, and underlying causes of recalls; (ii) clarification of procedures for conducting medical device recall audit checks to improve the ability of investigators to perform these checks in a consistent manner; (iii) development of explicit criteria for assessing whether recalling firms have performed an effective correction or removal action; and (iv) documentation of the FDA’s basis for terminating individual recalls. HHS reported that FDA plans to convene a working group to both evaluate improvements to the recall process and to develop strategies to implement the GAO's recommendations.

Tags: Other GAO Developments, FDA, Medical Devices

Posted on June 14, 2011 by Debra A. McCurdy

Lawmakers Seek Investigation of Physician Owned Distributors (PODs) for Medical Devices

A bipartisan group of lawmakers have requested that the OIG and CMS investigate “physician owned distributors” (PODs), described as arrangements under which a physician investor purchases ownership shares in an entity that then purchases or serves as a medical device distributor for the products the physician uses in surgery (primarily orthopedic implants). According to a Senate Finance Committee Minority analysis released by Ranking Republican Orrin Hatch, “[t]he very nature of PODs seem to create financial incentives for physician investors to use those devices that give them the greatest financial return and that, in the process, patient treatment decisions may be based on personal financial gain.” A group of lawmakers has asked the OIG and CMS to review the structure of PODs and their potential adverse impact on the Medicare program and its beneficiaries, including an examination of kickback concerns and treatment of these entities under the new ACO rules and the ACA's "Sunshine Act" disclosure provision. Additional information is available on Reed Smith's Life Sciences Legal Update blog.

Tags: Legislative Developments, Accountable Care Organizations, Fraud and Abuse, Medical Devices, Physicians

Posted on June 13, 2011 by Debra A. McCurdy

June Congressional Hearings on Health Policy Issues

Earlier this month, the House Oversight and Government Reform Health Care Subcommittee held a hearing on "Pathway to FDA Medical Device Approval: Is There a Better Way?"; the House Small Business Healthcare Subcommittee reviewed “Health IT Barriers for Small Medical Practices"; and the House Energy and Commerce Oversight and Investigations Subcommittee held a hearing on HHS regulatory reform. The Energy and Commerce Health Subcommittee also examined the ACA’s “Effects on Maintaining Health Coverage and Jobs: A Review of the Health Care Law's Regulatory Burden"; this hearing “reconvenes” on June 15. Also coming up, In addition, a House Judiciary Subcommittee on Crime hearing on June 14 will focus on the Foreign Corrupt Practices Act. On June 22, the House Ways and Means Health Subcommittee will hold a hearing on the Medicare program’s financial status. Looking ahead to next month, on July 13 the Energy and Commerce Health Subcommittee is holding a hearing entitled “IPAB: The Controversial Consequences for Medicare and Seniors.” Under the ACA, the new Independent Payment Advisory Board (IPAB) is charged with submitting detailed proposals to Congress and the President to reduce Medicare per-capita spending if projected spending growth exceeds a target. IPAB's proposals will go into effect automatically unless Congress enacts alternative legislation to achieve the required savings (with certain exceptions).

Tags: Legislative Developments, FDA, Fraud and Abuse, Health IT, Hearings and Markups, Independent Payment Advisory Board (IPAB), Medical Devices, Patient Protection and Affordable Care Act (PPACA), Regulatory review

Posted on May 31, 2011 by Debra A. McCurdy

Federal Agencies Outline Regulatory Review Plans

On May 26, 2011, the White House posted the preliminary regulatory reform plans submitted by individual federal departments and agencies under President Obama's Executive Order 13563. The agency plans include both discussions of general approaches to regulatory review and listings of specific regulations that may be revised. HHS lists numerous current regulations it identifies as candidates for regulatory review over the next two years in order to increase flexibility and reduce regulatory burdens. Such rules include, among many others, Centers for Medicare & Medicaid Services (CMS) rules on: quality reporting, Medicare appeals, hospital conditions of participation, and revisions to reduce documentation burdens and clarify requirements under a variety of payment rules (impacting inpatient rehabilitation facilities, ambulatory surgical centers, hospices, outpatient hospital departments, and physicians). The Food and Drug Administration (FDA) listing includes such items as revisions to the FDA's bar code rule, good manufacturing practice (GMP) regulations for both food and drugs, and medical device adverse event report requirements.

Tags: Appeals, Department of Health & Human Services, FDA, HOPPS, Hospice, Hospital, Medical Devices, Physicians, Quality Reporting, Regulatory review, ambulatory surgical centers

Posted on May 13, 2011 by Debra A. McCurdy

FDA Publishes Draft Guidance on Reprocessing of Reusable Medical Devices

This post was written by Paul Sheives.

The FDA has released for public comment a draft guidance document entitled “Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.” The recommendations in this guidance are intended to improve the safety and effectiveness of devices with processing or reprocessing labeling. The guidance addresses such topics as FDA’s seven criteria for reprocessing instructions, validation in accordance with the Quality System Regulations, and validation of cleaning methods for reprocessed devices. FDA is accepting comments on the document until August 1, 2011.

Tags: FDA, Food & Drug Administration Developments, Medical Devices

Posted on May 13, 2011 by Debra A. McCurdy

FDA to Hold Public Workshop on Reprocessing Reusable Medical Devices (June 8)

This post was written by Paul Sheives.

On June 8, 2011, FDA will hold a “Reprocessing of Reusable Medical Devices Workshop.” The meeting is part of FDA’s initiative to address patient exposure to inadequately-reprocessed reusable medical devices with the overall goal of reducing the risk of infection. Among the topics to be discussed at the workshop are: (1) factors affecting reprocessing quality, (2) device design as it relates to reprocessing reusable medical devices, (3) reprocessing methodologies, (4) validation methodologies, and (5) healthcare facility best practices. Registration for the meeting closes June 1, 2011, and it is also available via webcast. Attendees may also request to make a short presentation at the workshop.

Tags: Health Care Industry Events, FDA, Medical Devices

Posted on April 29, 2011 by Debra A. McCurdy

FDA Final Guidance Documents on Writing Requests for Product Designation

This post was written by Paul Sheives.

The FDA has released final “Guidance for Industry on How to Write a Request for Designation.” The guidance is intended to help industry understand the type of information FDA needs to determine the regulatory identity or classification of a product as a drug, device, biological product, or combination product, and to assign the product to the appropriate FDA component for review and regulation. The guidance provides general information about Requests for Designation (e.g., when to submit, how to appeal, meetings with FDA), and also sets forth the detail of what should be provided in a Request for Designation.

Tags: Other FDA Developments, Other HHS Developments, Drugs, FDA, Medical Devices

Posted on April 29, 2011 by Debra A. McCurdy

FDA Issues Guidance on Manufacturing Method/Process Changes

This post was written by Paul Sheives.

FDA has released a guidance document entitled “30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes.'' The guidance addresses the manufacturing method or process changes FDA believes may qualify for the 30-day notice of changes in manufacture method or processes changes, along with the changes that generally do not qualify. If the 30-day notice is insufficient, the manufacturer must file either a 135-day PMA or a 75-day HDE supplement relating to such changes. In addition, the guidance addresses the content for 30-day notices, FDA action on notices, and exceptions to user fees for 30-day notices.

Tags: Other FDA Developments, Other HHS Developments, FDA, Medical Devices

Posted on April 12, 2011 by Debra A. McCurdy

Congressional Hearings This Week on FDA Medical Device Approvals, Drug Imports/Diversion

On April 13, the Senate Aging Committee is holding a hearing entitled "A Delicate Balance: FDA and the Reform of the Medical Device Approval Process." In addition, the House Oversight and Government Reform Health Care Subcommittee is holding a hearing April 14 on "Pathway To FDA Medical Device Approval: Is There A Better Way?."

Separately, on April 13, the House Energy and Commerce Subcommittee on Oversight and Investigations has scheduled a hearing on “Import Safety: Status of FDA’s Screening Efforts at the Border.” On April 14, the Subcommittee on Commerce, Manufacturing, and Trade is holding a hearing on "Warning: The Growing Danger of Prescription Drug Diversion."

Tags: Health Care Industry Events, Legislative Developments, Drug Safety, Drugs, FDA, Hearings and Markups, Medical Devices

Posted on March 7, 2011 by Debra A. McCurdy

FDA Finalizes Medical Device Data Systems Rule

This post was written by Katie Hurley and Areta Kupchyk.

The FDA has published a final rule reclassifying Medical Device Data Systems (MDDS) as Class I medical devices exempt from 510(k) premarket notification requirements. FDA defines MDDS as medical devices that are intended to transfer, store, convert from one format to another according to preset specifications, or display “medical device data.” FDA explicitly excluded electronic health record (EHR) and computerized physician order entry (CPOE) systems from the MDDS final rule. The rule is effective April 18, 2011, and all manufacturers of MDDS must register their establishments and list their MDDS products with FDA by May 18, 2011. No later than April 18, 2012, all manufacturers of MDDS must develop and implement procedures to ensure compliance with Quality System Regulations and Medical Device Reporting requirements. For more information, see a Reed Smith alert analyzing the rule.

Tags: Department of Health & Human Services, Food & Drug Administration Developments, Medical Devices

Posted on February 18, 2011 by Debra A. McCurdy

Congressional Hearings

A number of recent Congressional hearings have focused on the Affordable Care Act, including: a House Ways and Means Committee hearing on the impact the ACA on Medicare and Medicare beneficiaries; House and Senate Judiciary Committee hearings on the constitutionality of the ACA’s individual health insurance mandate; a House Education and the Workforce Committee hearing on the impact of the ACA on the economy, employers, and the workforce; a House Small Business Committee hearing on the ACA’s administrative burdens; and a House Energy and Commerce hearing on Center for Consumer Information and Insurance Oversight issues. Other recent health policy hearings in the Finance Committee and Ways and Means Committee have addressed the President's FY 2012 budget proposal for HHS programs. Congress also has examined Medicare and Medicaid fraud and abuse and the impact of medical device regulation on jobs and patients.

Tags: Legislative Developments, Budget, Fraud and Abuse, Hearings and Markups, Medical Devices, Patient Protection and Affordable Care Act (PPACA)

Posted on February 10, 2011 by Debra A. McCurdy

FDA Launches Medical Device Initiative to Reform the 510(k) Process, Meeting Scheduled to Receive Feedback

This post was written by Paul Sheives and Areta Kupchyk.

The Food & Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has launched the Medical Device Innovation Initiative. This program is designed to facilitate patient access to transformative innovative devices, which historically have been slow to obtain market approval or clearance because of the scientific and regulatory challenges inherent in new technology. As part of the initiative, FDA released a report entitled “510(K) and Science Report Recommendations,” which follows the agency’s preliminary report and call for comment in August 2010. The report lays out a plan containing 25 actions FDA intends to implement during 2011 to improve the 510(k) clearance process. The key actions include: (1) streamlining the “de novo” review process for certain innovative, lower-risk medical devices; (2) clarifying when clinical data should be submitted in a premarket submission, guidance that will increase the efficiency and transparency of the review process; and (3) establishing a new Center Science Council of senior FDA experts to assure timely and consistent science-based decision making. CDRH will hold a public workshop on the Innovation Initiative on March 15, 2011 in Maryland to seek input on challenges associated with incentivizing innovation and the proposed solutions. The meeting will also be available via webcast. Registration for the meeting closes March 4, 2011. FDA is also accepting written comments until March 15, 2011.

Tags: Health Care Industry Events, Other FDA Developments, Other HHS Developments, FDA, Medical Devices

Posted on February 10, 2011 by Debra A. McCurdy

FDA Announces Texas Town Hall Meeting with CDRH Director

This post was written by Paul Sheives.

On March 10, 2011, the FDA is hosting a “Town Hall Discussion with the Director of the Center for Devices and Radiological Health and Other Senior Center Management” in Dallas, Texas. The scope of topics for the meeting is broad and is intended to cover topics of importance to the medical device industry, health care providers, and consumers. Although attendees may give short presentations at the meeting, the meeting will be open to discuss any relevant topics. Registration for the meeting closes February 25, 2011.

Tags: Health Care Industry Events, FDA, Medical Devices

Posted on February 10, 2011 by Debra A. McCurdy

FDA Public Workshop on Drug/Medical Device Regulatory Requirements (June 20-21)

This post was written by Paul Sheives.

FDA will hold a two-day public workshop entitled “The Future of Medical Products Regulation: Ensuring Safety and Integrity in a Global Market.” The workshop, to be held in Dallas, Texas on June 20-21, 2011, is intended to provide the drug and medical device industry information on the following topics: globalization, imports, and supplier controls; medical product theft and criminal investigations, proposed changes to the 510(k) review process; health fraud; streamlining the FDA enforcement process; the future of medical products regulation; medical devices in Canada; the Freedom of Information act; medical product complaint investigations; writing corrective and preventive actions procedures and documents to reflect compliance initiatives; and top ten FDA–483 objectionable observations. Registration for the workshop closes on May 24, 2011.

Tags: Health Care Industry Events, Drugs, FDA, Medical Devices

Posted on January 27, 2011 by Debra A. McCurdy

FDA Announces Plans to Reform 510(k) Process

This post was written by Jennifer A. Goldstein and Areta L. Kupchyk.

On January 19, 2011, FDA announced its long-awaited plans for revising the premarket notification (510(k)) process for medical devices to address the concerns that have been raised about the process by industry, consumers and Center for Devices and Radiological Health (CDRH) staff regarding the lack of predictability, consistency, transparency of the process, the inadequacy of the process to ensure the safety and effectiveness of products, and the lack of flexibility of the process to address changing technology and complexity. In 2009, CDRH established working groups to address these concerns. In August 2010, these working groups issued recommendations, which FDA analyzed and addressed as part of the announcement. FDA also sought public input and comments.

FDA’s Plan of Action for 510(k)s includes 25 action items for 2011, which include the majority of the working group recommendations that received overall support from the comments submitted to FDA. FDA states that it will focus first on implementing steps that will significantly impact fostering medical device innovation, enhancing regulatory predictability and improving patient safety. These steps include streamlining the review process for innovative, lower risk products (the “de novo” process), improving training for CDRH staff and industry, increase reliance on external experts, as well as addressing and improving CDRH processes. The Plan of Action includes an ambitious agenda to publish eight specific draft guidance documents between June – December 2011, on topics including:

What changes do or do not warrant submission of a new 510(k) and which modifications are eligible for a Special 510(k);
Clinical trials;
Class III designation (de novo);
Appropriate use of consensus standards;
Appealing CDRH decisions;
The 510(k) paradigm, to provide clarity on when clinical data should be submitted, submission of photographs or schematics, appropriate use of multiple predicates, criteria for identifying “different questions of safety and effectiveness,” resolving discrepancies between the 510(k) flowchart and the Federal Food, Drug, and Cosmetic Act, “intended use,” and 510(k) summaries;
Pre-submission interactions with CDRH; and
Product codes.

FDA announced that it intends to implement other recommendations, but only after stakeholder input. These recommendations include developing an online repository of medical device labeling and a public database of cleared devices that includes a photograph of each cleared device, while avoiding the disclosure of proprietary information. FDA also stated that it will further explore some of the other working group recommendations.

Finally, FDA identified some of the working group recommendations that were more controversial, such as consolidating the terms “indication for use” and “intended use,” expanding FDA statutory authority to consider off-label use when determining the intended use of a device and to require postmarket surveillance studies as a condition of clearance for certain devices, among others. FDA stated it will wait to decide whether to implement these recommendations until it receives feedback from the Institute of Medicine (IOM) as part of the IOM independent review of the 510(k) program that is currently underway.

Click here to view a copy of the Plan of Action for Implementation of 510(k) and Science Recommendations, which includes a description of the action item and date of completion.

Tags: Other FDA Developments, Other HHS Developments, FDA, Medical Devices

Posted on December 29, 2010 by Debra A. McCurdy

HHS Semiannual Regulatory Agenda for FY 2011

The Obama Administration has published its semiannual regulatory agenda outlining planned regulatory initiatives, including a number of major health policy rules. Specifically, the Administration identifies as key Department of Health and Human Services (HHS) priorities regulations addressing, among many other things: implementation of a variety of Affordable Care Act (ACA) insurance reform provisions (including rate review, uniform explanation of benefits, and appeal and external review process rules); notification requirements for long-term care facility closures; implementation of the ACA’s Community Living Assistance Services and Supports (CLASS) program; establishment of civil money penalties (CMPs) for noncompliant nursing homes; establishment of the ACA’s shared savings program for accountable care organizations (ACOs); revisions to HIPAA privacy and security enforcement regulations to comply with the provisions of the Health Information Technology for Economic and Clinical Health Act (HITECH) Act; Food and Drug Administration (FDA) rules to standardize the electronic submission of registrations and listings for devices, data from studies evaluating drugs and biologics for humans, and data on adverse events involving medical devices; an FDA rule establishing a unique identification system for medical devices; a proposed rule addressing the Office of Inspector General’s (OIG’s) authority to impose CMPs and assessments; and annual updates to various Medicare payment systems.

Tags: Accountable Care Organizations, Department of Health & Human Services, Drugs, FDA, Fraud and Abuse, Health IT, Insurance, Medical Devices, Nursing Homes, Patient Protection and Affordable Care Act (PPACA)

Posted on December 15, 2010 by Debra A. McCurdy

IRS Guidance on ACA Fee on Prescription Drug Manufacturers/Importers; Comment Request on Medical Device Excise Tax.

The Internal Revenue Service (IRS) has issued documents related to the annual fee for manufacturers and importers of brand name pharmaceuticals under section 9008 of the ACA, which is payable beginning in 2011. Specifically, IRS Notice 2010-71 describes a proposed methodology for calculating the fee (including a discussion of covered entities, sales taken into account; an adjustment methodology; information submission requirements; and the fee calculation methodology). It also describes how the IRS will provide each covered entity with a preliminary 2011 fee calculation that will serve as a basis for comments by the covered entity on the proposed methodology. Preliminary 2011 fee calculations will be based on information submitted by manufacturers on Form 8947, Report of Branded Prescription Drug Information, which should be submitted to the IRS by January 20, 2011. The preliminary fee will be calculated and sent to each covered entity by May 2, 2011. If the IRS subsequently promulgates regulations that modify the fee calculation methodology, the modified methodology will be used to determine final fee amounts for 2011 that will be sent to each covered entity by August 15, 2011. The IRS seeks comments on all aspects of its prescription drug fee procedures; comments are due June 2, 2011. A Reed Smith analysis of the guidance is available here. Separately, the IRS has released a request for public comments on issues to be addressed in future guidance on the new ACA excise tax on medical devices, which applies to sales of taxable medical devices after December 31, 2012. Comments specifically are requested on the excise tax exemption for any medical device “determined by the Secretary to be of a type which is generally purchased by the general public at retail for individual use,” and on issues pertaining to the application of existing Chapter 32 rules (pertaining to Manufacturers Excise Taxes) to this provision. The comment deadline is March 3, 2011. The solicitation notice (Notice 2010-89) will be published in IRB 2010-52, dated December 27, 2010.

Tags: Drugs, Medical Devices, PPACA Implementation, Patient Protection and Affordable Care Act (PPACA)

Posted on December 15, 2010 by Debra A. McCurdy

FDA Requests Notification of Intent to Participate in Medical Device User Fee Reauthorization Process

This post was written by Paul Sheives.

FDA has published a notice requesting that patient and advocacy groups notify FDA by January 6, 2011 if they intend participate in a series of public meetings on reauthorization of medical device user fees. The current authorization expires September 30, 2012. The first meeting will be held on January 13, 2011, and meetings will be held monthly during the negotiation process with regulated industry.

Tags: Department of Health & Human Services, FDA, Food & Drug Administration Developments, Medical Devices

Posted on December 14, 2010 by Debra A. McCurdy

FDA Public Workshop on Sentinel Initiative (Jan. 12)

This post was written by Paul Sheives.

FDA is holding its third annual public workshop on the Sentinel Initiative on January 12, 2011. The Sentinel Initiative involves a national electronic health information surveillance system to track the performance and safety of medical products once they are on the market. The Sentinel System will be created through public-private partnerships and will capitalize on existing large electronic claims and medical records data sources maintained by private and government entities that agree to participate in this nationwide effort. This meeting will focus on a variety of topics in active medical product surveillance, including an update on Mini-Sentinel and related activities, near-term plans for FDA’s Sentinel Initiative, and opportunities for coordination with other HHS efforts that use distributed systems of automated health care data.

Tags: Health Care Industry Events, Drugs, FDA, Medical Devices

Posted on December 6, 2010 by Debra A. McCurdy

CMS Meeting on New Technology Add-On Payments (Feb. 2, 2011)

On February 2, 2011, CMS is hosting a Town Hall meeting to discuss FY 2012 applications for new medical services and technologies add-on payments under the hospital inpatient prospective payment system (IPPS). Interested parties are invited to present recommendations and data regarding whether FY 2012 new medical services and technologies applications meet the substantial clinical improvement criterion. Additionally, CMS will hold an Informational Workshop for all interested parties on the application process for IPPS add-on payments for new medical services and technologies. The workshop also will cover applications for Medicare outpatient prospective payment system transitional pass-through payment for drugs, biological, and devices and new technology ambulatory payment classification group assignments for new services.

Tags: Health Care Industry Events, Drugs, HOPPS, Inpatient hospital, Medical Devices

Posted on October 29, 2010 by Debra A. McCurdy

Common Formats for Patient Safety Data Collection/Event Reporting

On October 22, 2010, the Agency for Healthcare Research and Quality (AHRQ) published a notice announcing the availability of a revised common format for reporting Device or Medical/Surgical Supply patient safety data. Specifically, the revised common format, “Device or Medical/Surgical Supply Including HIT Device,” now captures information about patient safety events related to health information technology.

Tags: AHRQ, Department of Health & Human Services, Health IT, Medical Devices, Patient Safety

Posted on October 15, 2010 by Debra A. McCurdy

FDA Seeks Comment on 5 Year Strategic Priority Plan

This post was written by Paul Sheives.

FDA seeks comments on the agency’s draft document, “Strategic Priorities FY 2011–2015.” The documents lists four key strategic priorities: (1) advancing regulatory science and innovation; (2) strengthening the safety and integrity of the global supply chain; (3) strengthening compliance and enforcement activities to support public health; and (4) expanding efforts to meet the needs of special populations. Also listed are four strategic program goals: (1) advancing food safety and nutrition; (2) promoting public health by advancing the safety and effectiveness of medical products; (3) establishing an effective tobacco regulation, prevention, and control program; and (4) managing for organizational excellence and accountability. FDA is accepting written comments on the document until November 1, 2010.

Tags: Department of Health & Human Services, Drugs, FDA, Food & Drug Administration Developments, Medical Devices, Public Health

Posted on September 17, 2010 by Debra A. McCurdy

Parallel CMS/FDA Review of Medical Products

On September 17, 2010, CMS and FDA published a notice announcing that they are considering establishing a process for overlapping evaluations of premarket, FDA-regulated medical products when the product sponsor and both agencies agree to such parallel review. The process is intended to reduce the time between FDA marketing approval or clearance decisions and CMS national coverage determinations, which the agencies hope could “potentially accelerate consumer access to new, particularly innovative, safe and effective medical products.” The agencies also observe that such parallel review could “create incentives for venture capitalists and companies to increase their investment in innovative medical products by reducing the time to return on investment” for eligible products. In the notice, the agencies are seeking public comments on the products that would be appropriate for this parallel review, what procedures should be developed, how a parallel review process should be implemented, and other operational issues. The agencies also are announcing their intent to create a pilot program for parallel review of medical devices. Comments are due December 16, 2010.

Tags: Centers for Medicare & Medicaid Services Developments, Coverage, Drugs, FDA, Food & Drug Administration Developments, Medical Devices

Posted on August 30, 2010 by Debra A. McCurdy

FDA Meeting on Medical Devices and Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations

This post was written by Paul Sheives.

FDA will hold a public meeting on September 23, 2010 to seek input on the manufacturing, characterization, and biocompatibility evaluation of medical devices containing or utilizing nanomaterials and nanostructures, including diagnostics. Meeting participants may either make a short oral presentation or participate in a round-table discussion. Registration for the meeting closes on September 15, 2010. The deadline for submitting written comments to be considered at the meeting is September 15, 2010, and all other comments will be accepted until October 22, 2010.

Tags: Health Care Industry Events, FDA, Medical Devices