No company wants to be on the receiving end of a Warning Letter, which is FDA’s primary tool for communicating to a company that it has been found to be in significant violation of regulatory requirements. Typically, a company who receives a Warning Letter must …
While this author needs no excuse to listen to Van Halen, one surprising source of inspiration came while reviewing the body of guidance documents issued by CDRH in the last year. While CDRH issued between 38 and 48 new draft or final guidance documents in …
As we previously discussed, FDA recently held two meetings that, while separate, provided a cohesive discussion of the use of Real World Evidence (RWE) and Artificial Intelligence (AI) in regulatory decision making. The discussions during the Artificial Intelligence in Drug & Biological Product Development meeting …
FDA’s recent support and presentations at meetings on Regulatory Submissions with Real-World Evidence: Successes, Challenges, and Lessons Learned (RWE Meeting) and Artificial Intelligence in Drug & Biological Product Development (AI Meeting) provided updates on the current status of these initiatives at FDA, while also showing …
Secretary of Health and Human Services Robert F. Kennedy, Jr., did not hide his disdain for FDA prior to his appointment, stating: FDA’s war on public health is about to end. This includes its aggressive suppression of psychedelics, peptides, stem cells, raw milk, hyperbaric therapies, chelating …
On September 30, 2025, FDA released a Request for Public Comment: Measuring and Evaluating Artificial Intelligence-enabled Medical Device Performance in the Real-World. Comments are due to the docket by December 1, 2025. The request for comments is to obtain feedback about the “current, practical approaches to …
On September 29, 2025, FDA announced that it would be expanding its use of “Early Alert” communications for potentially high-risk device recalls, having determined that the pilot of this program was a success. The pilot program, initiated November 21, 2024, sought to minimize the time …
On September 26, 2025, the Department of Commerce published a notice requesting public comment on “an investigation to determine the effects on the national security of imports of personal protective equipment (PPE), medical consumables, and medical equipment including devices.” 90 Fed. Reg. 46383 (Sept. 26, …
On September 19, 2025, FDA published in the Federal Register a final rule reverting the regulatory definition of “in vitro diagnostic products” (IVD products) in 21 C.F.R. § 809.3 to the text as it existed prior to the effective date of the May 2024 LDT …
Hyman, Phelps & McNamara, P.C. (HPM) is excited to announce speakers for the program 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. HPM’s Michelle …
A recent Warning Letter to a dental laboratory offering direct-to-consumer dental prosthetics highlights the ambiguous regulatory position occupied by dental laboratories and the products they produce for patients. In June 2025, the dental laboratory Reset Technology Corporation received a Warning Letter identifying several areas of …
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 …
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 …
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 …
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 …
