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  • Medical Devices

    • FDA Finalizes Guidance on Process to Request Review of CFG DenialNovember 14th, 2019

      FDA is issuing final guidance on how device firms may request review of a decision to withhold issuance of a Certificate to Foreign Government (CFG).  What is a CFG?  In many cases, foreign governments will seek official assurance that products exported to their countries are …

    • FDA Law Alert – November 2019November 6th, 2019

      Hyman, Phelps & McNamara, P.C. is pleased to publish the third installment of the FDA Law Alert, a quarterly newsletter highlighting key postings from our nationally acclaimed FDA Law Blog.  Please subscribe to the FDA Law Blog to receive contemporaneous posts on government regulatory and …

    • Regulation of Laboratory Developed Tests by FDA: Time for the Agency to Cease and Desist Until Congress Enacts LegislationOctober 21st, 2019

      A warning letter issued earlier this year by the Food and Drug Administration (FDA) to Inova Genomics (Inova) prompts some reflections on where things stand now with the regulation of laboratory developed tests (LDTs) under the Federal Food, Drug, and Cosmetic Act (FDCA).  An LDT, …

    • Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures ActOctober 4th, 2019

      Nearly three years after Section 3060(a) of the 21st Century Cures Act amended section 520 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by removing certain software functions from the device definition in section 201(h) of the FD&C Act, FDA has released Changes to …

    • FDA Issues a Second Draft Guidance for Clinical Decision Support SoftwareOctober 1st, 2019

      On September 27, 2019 FDA issued several updates to advance their digital health policies.  One of these updates was a new draft guidance, Clinical Decision Support Software (“Guidance”).  This draft guidance replaces the 2017 draft guidance, Clinical and Patient Decision Support Software (“Prior Draft”), which …

    • CDRH Issues Draft Guidance on Safer Technologies ProgramSeptember 30th, 2019

      FDA formally announced the Safer Technologies Program (STeP) in a December 2018 press release from then-FDA Commissioner Scott Gottlieb, M.D., and Director of CDRH Jeff Shuren, M.D.  Details on the program were limited other than to say that the program would be designed to complement …

    • Patients Know Best: FDA Releases Draft Guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical InvestigationsSeptember 27th, 2019

      There is little or no debate that patients are the experts on their own diseases.  The FDA has promoted this concept for years and on September 24, 2019, the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) …

    • FDA Finalizes Updates to the Special 510(k) ProgramSeptember 19th, 2019

      On September 13, 2019 FDA issued a final guidance document The Special 510(k) Program (“Guidance”).  We blogged about the prior draft guidance here.  This Guidance, along with The Abbreviated 510(k) Program, supersedes the 1998 guidance document The New 510(k) Paradigm – Alternate Approaches to Demonstrating …

    • CDRH Issues Final Guidance on De Novo Submission Acceptance ReviewSeptember 13th, 2019

      On September 9, 2019, FDA issued a final guidance, Acceptance Review for De Novo Classification Requests.  The guidance is meant to provide clarity on the Agency’s expectations for information to be submitted in a De Novo request and to ensure predictability and consistency for sponsors.  …

    • Deference to Agency DeferenceAugust 27th, 2019

      Companies challenging FDA in court typically face a steep uphill battle given the long-standing doctrine known as Auer deference, which (in simplified terms) requires courts to defer to FDA’s interpretation of its own regulations if they are ambiguous.  The recent Supreme Court ruling in Kisor …

    • FDA Law Alert: Issue #2August 7th, 2019

      Hyman, Phelps & McNamara, P.C. is pleased to publish this second issue of the FDA Law Alert, a newsletter highlighting key postings from our nationally acclaimed FDA Law Blog.  Please subscribe to the FDA Law Blog to receive contemporaneous posts on government regulatory and enforcement …

    • FDA Issues Final Guidance on Postmarketing Safety Reporting for Combination ProductsAugust 5th, 2019

      FDA recently finalized the guidance document, Postmarketing Safety Reporting for Combination Products (“PMSR Guidance”).  The PMSR Guidance addresses compliance with the final rule on postmarketing safety reporting (PMSR) requirements, 21 C.F.R. Part 4, Subpart B (“PMSR final rule”), for combination products.  This is a complicated …

    • PMA Panel Votes: More Than Meets the EyeJuly 11th, 2019

      FDA advisory panel meetings to review pre-market applications (PMAs) are high-stakes events.  While FDA is not bound by the vote of the advisory panel, it has been long-accepted that the agency typically follows the recommendation of the panel. Which got us thinking:  are conventional wisdom and …

    • Cybersecurity Fears Lead to Insulin Pump RecallJuly 3rd, 2019

      On June 27, Medtronic announced that it was recalling certain MiniMed insulin pumps due to “potential security vulnerabilities.”  On the same day, FDA issued a Safety Communication and the Department of Homeland Security issued a Cybersecurity Infrastructure Security Advisory about the same issue. FDA’s Safety Communication …

    • Device Manufacturer’s Criminal and Civil Penalties Deserve Closer AttentionJuly 2nd, 2019

      Today’s blog post illustrates how a company’s problems can escalate rapidly from an administrative warning letter to the full weight of the criminal system.  The unfortunate subject is ACell, a manufacturer of medical devices derived from porcine urinary bladder material.  ACell received a Warning Letter …