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The Food and Drug Administration (FDA) recently released new draft guidance documents to clarify its approach to regulating software as a medical device. The first draft guidance, Clinical and Patient Decision Support Software, addresses provision of the 21st Century Cures Act that exempts certain clinical decision support software from the definition of a medical device. 

The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has released the 2017 edition of its Compendium of Unimplemented Recommendations  (“Compendium”). In the Compendium, OIG identifies the top 25 unimplemented recommendations that HHS would need to prioritize in order to facilitate OIG’s recommendations on cost savings, program effectiveness, efficiency, and quality improvements in HHS programs. More than half of these top 25 recommendations focus on programs regulated by the Centers for Medicare & Medicaid Services (CMS), while others focus on programs regulated by other HHS agencies and states. The top priorities identified by the OIG in the Compendium include recommendations broadly aimed at:

  • Protecting beneficiaries from drug abuse, including opioid abuse
  • Ensuring program integrity, quality of care, and safety in programs that serve children
  • Reducing Medicaid fraud and patient harm, including in the delivery of personal care services
  • Reducing home health fraud
  • Promoting economy and efficiency in drug pricing and reimbursement

Continue Reading OIG Issues Top 25 Unimplemented Cost-Savings and Quality-Improvement Recommendations for HHS Programs

The Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) have announced that they are making permanent their “Program for Parallel Review of Medical Devices,” which is now operating as a pilot program.  The parallel review initiative allows concurrent FDA and CMS review of a medical device with the goal

The National Institutes of Health (NIH) has finalized the requirements for submitting clinical trial information for applicable clinical trials of drug products (including biological products) and device products on The rule is intended to clarify as well as establish additional procedures and requirements for submitting: (i) registration, (ii) summary results, and (iii) adverse event information for such applicable clinical trials.

According to NIH, the expanded registry and results data bank will “help patients find trials for which they might be eligible, enhance the design of clinical trials and prevent duplication of unsuccessful or unsafe trials, improve the evidence base that informs clinical care, increase the efficiency of drug and device development processes, improve clinical research practice, and build public trust in clinical research.”  Among other things, the final rule:
Continue Reading NIH Finalizes New Drug and Device Clinical Trial Reporting Requirements