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  • Medical Devices

    • Submitting a 510(k)? Keep Hoarding Blank CDsNovember 9th, 2021

      FDA introduced electronic copies (eCopies) of 510(k)s in 2013 (see our prior blogs here and here) as a way to reduce the need for submission of paper copies of 510(k)s to the Agency.  An eCopy is an electronic copy of the 510(k) that is comprised …

    • FDA Publishes De Novo Classification Final Rule with Few Changes from the Proposed RuleOctober 26th, 2021

      After 23 years, de novo classification review finally has an implementing regulation! The other major review processes have had their regulations in place for many decades.  The Medical Device Amendments of 1976 created the initial premarket application (PMA) review and 510(k) substantial equivalence review processes.  Only …

    • FDA Issues Unsupported Safety Warning Regarding Surgical Robots for Cancer TreatmentOctober 15th, 2021

      In recent years, for novel robot assisted surgery (RAS) devices, FDA’s Center for Devices and Radiological Health (CDRH) has taken the approach of clearing RAS devices for specific indications for use.  Gone are the days of tool type indications for this type of device.  Rather, …

    • HP&M’s Jeff Shapiro and Serra Schlanger to Present on Advertising and PromotionSeptember 23rd, 2021

      Hyman, Phelps & McNamara, P.C. is pleased to announce that Jeffrey Shapiro and Serra Schlanger will present at this year’s Food and Drug Law Institute virtual Advertising and Promotion for Medical Products Conference on October 13–15.  This conference will analyze the latest regulatory issues related …

    • FDA Wants Your Input on Cybersecurity for Servicing of Medical DevicesAugust 31st, 2021

      On June 17, 2021, FDA has released a discussion paper to discuss cybersecurity issues related to the servicing of medical devices. We have previously posted blogs about FDA’s increasing interest on cybersecurity both in the premarket (see our past blog posts here, here, and here) and the postmarket …

    • DOJ Re-Brands Guidance DocumentsAugust 30th, 2021

      Companies often use rebranding to reposition and refocus their business.  Sometimes they do it with great fanfare; sometimes it is done quietly and incrementally.  The federal government does its own version of rebranding with each change in administration.  Just before the July 4 holiday weekend, …

    • The 6-Year Saga Finally Ends: FDA Issues Final Rule Modifying The Intended Use RegulationAugust 16th, 2021

      A determination of “intended use” is fundamental to FDA’s regulation of drugs and medical devices.  It is a primary basis for determining if an article is regulated by FDA at all, and if so, what regulatory requirements apply.  It is embodied in parallel drug and …

    • FDA Announces It Will Now Regulate Devices as DevicesAugust 10th, 2021

      On the heels of Genus Medical Technologies’ successful lawsuit against FDA—Genus was represented by Hyman, Phelps & McNamara PC—in both the District Court of D.C. and the Court of Appeals for the D.C. Circuit, FDA published a Federal Register Notice today (August 9) soliciting comments …

    • A VALID Argument: Proposed Legislation Would Reshape Regulation of DiagnosticsJuly 9th, 2021

      For many years, one of the most controversial topics in device regulation has been the dual-track oversight of in vitro diagnostics (IVDs) and laboratory developed tests (LDTs).  Distributed IVD products are regulated by FDA, while laboratories that perform LDTs are regulated by the Centers for …

    • FDA Medical Device Ban Overturned For the First TimeJuly 7th, 2021

      In the first challenge ever brought against FDA’s rarely used power to ban a medical device, a court found FDA overstepped its authority and overturned the ban.  In March 2020, FDA issued a final rule that banned the use of Graduated Electronic Decelerators (GEDs) to …

    • FDA Issues Draft Guidance Distinguishing Remanufacturing from ServicingJune 25th, 2021

      On June 18th, FDA published a draft guidance document titled Remanufacturing of Medical Devices, which has been several years in the making.  The draft guidance distinguishes between “remanufacturing” and “servicing” of devices.  This distinction can be critical, due to the significantly increased regulatory requirements that …

    • Modernizing The Regulation of Laboratory Developed Tests (LDTs): Senator Rand Paul Identifies A Better Way ForwardJune 14th, 2021

      In our last post on Laboratory Developed Tests (LDTs), we suggested that Congress, not FDA, should lead in directing modernization of LDT regulation.  Any change should be made by enacting new law, and not by Food and Drug Administration (FDA) administrative fiat. Coincidentally, on the same …

    • Laboratory Developed Tests: Members of Congress Ask FDA to Do Their Job for ThemMay 18th, 2021

      You may recall that last summer (on August 19), the Department of Health and Human Services (HHS) ordered the Food and Drug Administration (FDA) to cease premarket review of laboratory developed tests (LDTs), including COVID‑19 LDTs.  At the time, we wrote favorably about this move.  …

    • New Administration, “Old” Rules: FDA and HHS Jointly Withdraw 11th Hour Trump Administration Proposal for Sweeping 510(k) ExemptionApril 22nd, 2021

      In a return to regular order, on April 16, HHS and FDA jointly withdrew a January 15, 2021 proposal issued by HHS under the prior administration recommending wide-spread 510(k) exemptions (the “Notice”).  See 86 Fed. Reg. 20167, 20174 (Apr. 16, 2021) (available here and here).  …

    • OHT-7’s Q1 2021 Report Card on EUA ReviewsApril 14th, 2021

      During the February 3rd meeting of the IVD Town Hall that OHT-7 has been hosting since early on the pandemic Office Director Timothy Stenzel proudly proclaimed: We have also really have ramped up our decisions. So we are currently over the last week averaging about nine …