Tag Archives: Medical Devices

FDA Announces Medical Device User Fee Rates for Fiscal Year 2016

Earlier this week, the federal Food and Drug Administration (FDA) issued a notice in the Federal Register (80 Fed. Reg. 46033) announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2016, which apply from October 1, 2015 through September 30, 2016. The Federal Food, Drug, and Cosmetic Act … Continue Reading

FDA,OHRP Considering Guidance on Use of Electronic Informed Consent In Clinical Investigations

As discussed on our sister blog, Life Sciences Legal Update, the FDA has published a notice soliciting comments on a draft guidance document on the use of electronic media and processes to obtain informed consent for FDA-regulated clinical investigations of medical products.  The HHS Office for Human Research Protections (OHRP) also is considering whether to adopt … Continue Reading

Congressional Panels Take Steps to Speed Patient Access to Medical Innovation

On January 27, 2015, the House Energy and Commerce Committee released its “21st Century Cures Act” discussion draft, the product of a year-long, bipartisan effort by the Committee to accelerate the pace of medical cures in the United States. The nearly 400-page bill addresses a wide range of topics, including, among many other things: the … Continue Reading

FDA Releases Final Medical Device Cybersecurity Guidance, Schedules Workshop on Topic

Yesterday the FDA issued final guidance entitled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” which includes recommendations for medical device manufacturers on cybersecurity management and information that should be included in a pre-market submission. The recommendations are intended to supplement previous FDA guidances, “Guidance for the Content of Premarket Submissions for Software … Continue Reading

FDA Will Not Enforce Compliance for Mobile Device Data Systems and Other Low Risk Devices, Agency Reports

In a new draft guidance document, the Food and Drug Administration (FDA) has announced that it does not intend to enforce compliance with general regulatory controls that apply to Medical Device Data Systems (MDDS), medical image storage devices and medical image communications devices. MDDS refers to hardware and software that transfers, stores, converts format and … Continue Reading

FDA Releases Drug/Device Industry Social Media Guidance Documents

The FDA released two draft social media guidance documents last week, describing how manufacturers, packers and distributors of prescription drugs and medical devices may: (1) communicate both benefit and risk information on Internet/social media platforms with character space limitations, and (2) correct independent third-party misinformation about a firm’s products.  For details, see Reed Smith’s Client … Continue Reading

FDA Workshop to Focus on 3-D Printing of Medical Devices

According to the Food and Drug Administration (FDA), additive manufacturing, also known as 3-D printing, is entering mainstream use in medical devices, both as an alternative device production method for traditional components and as a method to create patient-matched devices. FDA has begun to receive submissions using additive manufacturing for medical devices, and the agency … Continue Reading

CMS Invites Comments on Sunshine Act “Open Payments” Dispute Resolution/Corrections Process

CMS is inviting comments on the Physician Payment Sunshine Act “Open Payments Program” dispute resolution and corrections process. As previously reported, the Physician Payment Sunshine Act requires pharmaceutical and medical device manufacturers and group purchasing organizations (GPOs) to register with and submit to CMS data on their financial relationships with physicians and teaching hospitals. This … Continue Reading

Busy Week for FDA’s Center for Devices and Radiological Health

This post was written by Jillian W. Riley. Earlier this week, FDA’s Center for Devices and Radiological Health (CDRH) published two separate draft guidance documents to advance the dual goals of FDA and industry to provide pathways for medical devices to reach the market quickly while ensuring the safety and efficacy of the product. The … Continue Reading

Will Physician Payment Sunshine Act Data Usher in a New Era of False Claims Act Litigation?

While attention has been focused on Medicare physician payment data released by CMS yesterday, upcoming Sunshine Act data will shine a new spotlight on financial relationships between physicians and pharmaceutical and medical device companies - with potential False Claims Act (FCA) implications. Specifically, last week marked the deadline for pharmaceutical and medical device manufacturers and group purchasing organizations (GPOs) to register with and submit aggregate 2013 payment and investment interest data to the Centers for Medicare & Medicaid Services (CMS) on certain financial relationships between themselves and physicians and teaching hospitals, as required by the Physician Payment Sunshine Act. In May, manufacturers and GPOs will be required to submit to CMS detailed 2013 payment data. With some exceptions, CMS will be making these data public by September 1, 2014. While the publicly-available data are intended to provide more transparency for patients, to allow them to have a better understanding of the financial relationships between physicians and pharmaceutical and medical device companies, patients will certainly not be the only group interested in this public information. It is likely that the Department of Health and Human Services Office of the Inspector General, Department of Justice, and relators' attorneys will utilize these data to initiate investigations and support complaints under the federal FCA.… Continue Reading

FDA Proposal Amends Medical Device Classification Rules

This post was written by Jennifer Pike. On March 25, 2014, the Food and Drug Administration (FDA) published a proposal to amend its regulations governing the classification and reclassification of medical devices. In addition to conforming the regulations to recent changes made by the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA), the … Continue Reading

Advisory Panel Recommends Access Standards for Medical Diagnostic Equipment

The Access Board’s Medical Diagnostic Equipment Accessibility Standards Advisory Committee has issued its final report on “Advancing Equal Access to Diagnostic Services: Recommendations on Standards for the Design of Medical Diagnostic Equipment for Adults with Disabilities.” The report includes detailed recommendations on standards for access to equipment such as examination tables and chairs, weight scales, … Continue Reading

CMS, FDA Extend Pilot Program for Parallel Review of Medical Products

In October 2011, CMS and the FDA formally launched a voluntary parallel review pilot program for sponsors of medical devices. At the time, the agencies stated that they intended to run the pilot program for two years, with the possibility of an extension. In a December 18, 2013 notice, the FDA and CMS announced that … Continue Reading

CMS Revises Hospital Equipment Maintenance Requirements

CMS has issued updated survey guidance clarifying requirements for hospital maintenance of facilities, supplies, and equipment.  Most notably, under certain circumstances, CMS is allowing a hospital to adjust its maintenance, inspection, and testing frequency and activities for facility and medical equipment from what is recommended by the manufacturer, based on a risk-based assessment performed by … Continue Reading

DOJ Touts $3.8 Billion in FY 2013 False Claims Act Recoveries

The Department of Justice (DOJ) recently announced that it recovered $3.8 billion in settlements and judgments in civil False Claims Act cases in fiscal year (FY) 2013, including health care fraud recoveries totaling approximately $2.6 billion. The DOJ notes that about $1.8 billion in recoveries involved alleged false claims for drugs and medical devices under … Continue Reading

OIG Highlights Volume of Spinal Surgeries Tied to Physician-Owned Distributors (PODs)

A recent OIG report links the growing presence of physician-owned distributorships, or PODs, to increased spinal surgery volumes and potentially increased Medicare costs. The OIG notes a “substantial presence” of PODs in the spinal device market, with PODs supplying spinal devices for 19% of the spinal fusion surgeries billed to Medicare in FY 2011. According … Continue Reading

China Life Sciences Regulatory Crackdown Spreads to Medical Device Sector

As reported on Reed Smith’s Life Sciences Legal Update blog, the local Beijing office of the Ministry of Health (MOH) of the People’s Republic of China recently announced that it has started a three-month review of the use of high-value medical consumables and large-scale medical equipment in Beijing. Noting that prior inspections of hospitals had … Continue Reading

CMS Revises Medicare National Coverage Determination Process, Eases Path to Discontinue Outdated Coverage Policies

CMS has announced updates to the process for making Medicare national coverage determinations (NCDs) to provide clarity and transparency with regard to modifications made to the coverage process since the Medicare Modernization Act. Among other things, the notice addresses: the procedures for requesting an NCD or reconsideration of an existing NCD; public participation in the … Continue Reading

In Advance of Sunshine Act Reporting, CMS Releases Physician & Industry Resources

Data collection under the ACA Physician Payment Sunshine Act begins on August 1, 2013. To assist covered manufacturers of pharmaceuticals or medical devices with reporting obligations, CMS has announced new “OPEN PAYMENTS” mobile applications that could be used to track payments and other financial transfers.  While physicians are not required to report any information, CMS notes … Continue Reading

Draft FDA Guidance Recommends Cybersecurity Risk Assessments and Management Plans for Premarket Medical Device Submissions

The Food and Drug Administration (FDA) has announced the availability of a new draft guidance document entitled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” The draft guidance identifies cybersecurity issues that medical device manufacturers should consider in preparing premarket submissions for medical devices – including Premarket Notifications (510(k)), Premarket Approval Applications … Continue Reading

OIG Special Fraud Alert Deems Physician-Owned Distributors (PODs) As “Inherently Suspect” Under Anti-Kickback Statute

On March 26, 2013, the HHS Office of Inspector General (OIG) released a Special Fraud Alert highlighting the risks associated with PODs — physician-owned entities that sell (or arrange for the sale of) implantable medical devices ordered by their physician-owners for use in procedures the physician-owners perform on their own patients at hospitals or ambulatory … Continue Reading

FDA Issues New Guidance Documents

In recent weeks, the Food and Drug Administration (FDA) has issued a number of new draft and final guidance documents on a range of issues, including financial disclosure by clinical investigators, medical device recalls, prescription drug labeling, and medical devices for pediatric uses. Highlights include the following: Financial Disclosure by Clinical Investigators. This final guidance … Continue Reading

CMS Releases Physician Payments Sunshine Act Final Rule

The Centers for Medicare & Medicaid Services (CMS) released late today its final 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 … Continue Reading