• where experts go to learn about FDA
  • Véronique Li, Senior Medical Device Regulation Expert

    • 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 …

    • 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 …

    • To 513(g) or not to 513(g)? That is the questionNovember 8th, 2024

      In most instances, it is clear if a product will be considered a “device” under the Federal Food, Drug, and Cosmetic Act (FD&C Act).  Sometimes, though, the question of classification defies an easy answer.  When a company is unsure if its product is a device, …

    • Where Have All the De Novo Summaries Gone: An UpdateSeptember 4th, 2024

      Thank you to readers of this blog. We received incredible feedback on our August 19 post analyzing the number of decision summaries that have been posted for De Novos. We are happy to report that fifteen new decision summaries have been posted as of August 28. …

    • Long Time Passing: Where Have All the De Novo Decision Summaries Gone?August 19th, 2024

      In 1997, Congress wisely amended the Federal Food, Drug, and Cosmetic Act (FDCA) by adding Section 513(f)(2) to establish the De Novo process.  The De Novo process provides a regulatory pathway to classify novel devices for which general controls alone or general and special controls …

    • The Summit for Women Leaders in Life Sciences LawJuly 31st, 2024

      The American Conference Institute (“ACI”) held its 11th Annual Summit for Women Leaders in Life Sciences Law at the Seaport Hotel in Boston, Massachusetts on July 25th & 26th of last week.  Several leading ladies in law at HPM attended the conference and, based on their …

    • Better Late Than Never – Unpacking FDA’s Highly Anticipated (and Long Overdue) Draft Guidance on Diversity Action PlansJuly 10th, 2024

      The Food and Drug Omnibus Reform Act (“FDORA”), enacted in December 2022, added a requirement that sponsors submit Diversity Action Plans (“DAPs”) for certain clinical studies involving drugs, biological products, or devices (codified at 21 U.S.C. § 355(z)(3) and 21 U.S.C. § 360j(g)(9)(A)).  For drugs, …

    • When Worlds Collide: The Theory of Real-World Evidence Meets Reality – Part IIMay 23rd, 2024

      We recently blogged about the Center for Devices and Radiological Health’s (CDRH) reluctance to make full use of real-world data (RWD) and real-world evidence (RWE) to support marketing applications.  In response to the post, we did receive feedback from a company that had had the …

    • When Worlds Collide: The Theory of Real-World Evidence Meets RealityMay 14th, 2024

      FDA has long touted the use of real-world evidence (RWE).  Extolling RWE, FDA has said “RWE can be leveraged to bring new products to market, evaluate the safety and effectiveness of existing products for new uses, and assess the continued performance and safety of products …

    • FDA Grants A Registration Fee Waiver for Very Small, Broke Device ManufacturersMarch 8th, 2024

      Our last post on small business certification requests described how small medical device manufacturers, defined as those with gross receipts of less than $100 million in gross receipts and sales for the most recent tax year, are eligible for a reduced fee on those medical …

    • How to Run DMC? It’s Tricky – FDA’s New Draft Guidance Provides Updated Recommendations on How to Best Use Data Monitoring Committees in Clinical TrialsMarch 7th, 2024

      The trio of CDER, CBER, and CDRH released a new draft guidance titled “Use of Data Monitoring Committees in Clinical Trials” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance.  The new …

    • Why, Who, When, Where and More: New Draft Guidance on Notifying FDA about Discontinuance or Interruption in ManufacturingMarch 5th, 2024

      On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act. The draft guidance provides recommendations for applicants and manufacturers about the requirements …

    • FDA Issues Long-Awaited QMSR Final RuleFebruary 22nd, 2024

      More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. The final rule emphasizes risk management activities and risk-based decision making. …

    • FDA Improves the Process for Filing Complaints About Medical Device CompaniesOctober 27th, 2023

      In our June blog post, we reported on FDA’s request for comments about its program to receive information from the public alleging misconduct by other companies.  FDA uses this program to help it identify risks and to determine whether further investigation is needed.  Because this …