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  • Medical Devices

    • What Does a DOJ Settlement Have in Common with a Good Book? They Both can Change Your Life*August 15th, 2025

      The authors of this post are both avid bibliophiles, and keenly appreciate the hook of a good title or first sentence that draws you right in. Usually the titles of government press releases do not share this allure, but there was one recently that caught …

    • MDUFA VI Reauthorization Public Meeting Hears Many Perspectives on Device User FeesAugust 12th, 2025

      On August 4, 2025, FDA hosted a public meeting related to the reauthorization of the Medical Device User Fee Act for fiscal years 2028 through 2032 (MDUFA VI).  The FDA invited public comment on the following questions and most speakers remarks provided perspectives related to …

    • FDA Formally Rescinds the LDT Final Rule Following Defeat in CourtAugust 11th, 2025

      On August 6, 2025, the Office of Information and Regulatory Affairs (OIRA) published a notice that FDA has rescinded the Laboratory Developed Test (LDT) Final Rule that was vacated earlier this year by the U.S. District Court for the Eastern District of Texas. The rescission …

    • Silicon Valley Life Sciences DayAugust 7th, 2025

      Hyman, Phelps & McNamara, P.C. (HPM) is excited to announce a program that we are co-hosting with Freshfields geared toward early-stage biotech and medtech companies. This program will be a half-day, in-person event at Freshfields’ Silicon Valley office on Wednesday September 10, 2025, and will feature …

    • Leading the Way: Highlights from the 12th Annual ACI Women Leaders in Life Sciences Law SummitAugust 6th, 2025

      Boston was once again the hub for female leadership in life sciences law this summer as attorneys, executives, and policymakers gathered for the 12th Annual American Conference Institute (“ACI”) Women Leaders in Life Sciences Law Summit on July 30–31, 2025. Hosted at the Seaport Hotel, the …

    • A Software Demo is Worth a Submission Full of Screenshots, But Is An Early Orientation Meeting Worth the Time?July 30th, 2025

      On July 24, 2025, FDA released the Regulatory Accelerator, an initiative to help digital health sponsors bring their technology to market. New developers may want to bookmark this link as the initiative neatly corrals information in one place. For those who have been working in …

    • FDA’s Latest Lists for Digital Health TechnologiesJuly 29th, 2025

      FDA announced earlier this month that it had updated its list of artificial intelligence (AI)-enabled medical devices and created new lists for medical devices that incorporate augmented reality or virtual reality and medical devices that incorporate sensor-based digital health technology.  The list for AI-enabled devices …

    • Whose 510(k) Is It Anyway?July 25th, 2025

      FDA recently released a draft guidance regarding the transfer or sale of a 510(k) clearance. When a 510(k) for a device is sold or transferred from one entity to another, the new 510(k) holder must list the device with the FDA.  If the device has …

    • To Meet or Not to Meet: Day 70 and CountingJuly 18th, 2025

      Recent communications from CDRH indicate that impacts to resources from Reductions-In-Force are causing some Offices in CDRH to delay granting a request for a pre-submission (or Q-Submission) meeting until after written feedback is provided. In a pre-submission, the Sponsor can request written feedback only, but …

    • Blood Pressure Rising: FDA Warning Letter Takes an Aggressive Approach on General Wellness ProductJuly 17th, 2025

      At the end of June, HHS Secretary Robert F. Kennedy told a House congressional committee that he would like to see all Americans make use of wearable products, such as Apple Watch, Oura Rings, Fitbits, and WHOOP, to “take control of their health.” Less than …

    • Federal Hiring Shake-Up (Again): What the Latest Executive Action and Supreme Court Decision Mean for IndustryJuly 14th, 2025

      On July 7, 2025, President Trump, via Executive Order (“EO”), issued a presidential memorandum and accompanying fact sheet directing major changes in federal civilian hiring, including extending the federal civilian hiring freeze through October 15, 2025.  Under the titular theme “Ensuring Accountability and Prioritizing Public …

    • Better Late Than Never: FDA Published FR Notices For De Novo Classifications Dating As Far Back as 2013July 7th, 2025

      In late June, FDA published five Federal Register notices that caught our eye, particularly for the dates the classifications were first applicable. Each notice listed the action as “Final amendment; final order” rather than “Final order.” This editorial change began in December 2019 to indicate that …

    • The RFD Process: Time for Reform?June 30th, 2025

      The Federal Food, Drug, and Cosmetic Act (FD&C Act) has very different regulatory regimes for pharmaceutical products than devices. Knowing how a product will be regulated is essential to companies. The means to gaining that knowledge for combination products or single entity products where the …

    • Last Friday was a Good Day for Those Who Want to Litigate Against the Federal GovernmentJune 23rd, 2025

      Last Friday, the Supreme Court delivered a trio of decisions making it easier to litigate against the federal government.  The facts and law in each case matter, and as is often the case when the Supreme Court “decides” an issue, much remains to be seen.  …

    • Time is Money and Money is Time…What is an SBD Worth?June 6th, 2025

      We have written many posts (here, here, here, and more) about the impact of the reductions in force (RIFs) on various activities across FDA. One area where the RIFs are beginning to have an impact is with respect to Small Business Determination (SBD) requests submitted …