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On August 6, 2025, the Office of Information and Regulatory Affairs (OIRA) published a notice that FDA has rescinded the Laboratory Developed Test (LDT) Final Rule that was vacated earlier this year by the U.S. District Court for the Eastern District of Texas.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