Two recently published FDA warning letters caught our attention as they cite manufacturers for failing to submit a 510(k) for changes to device materials. FDA’s guidance Deciding When to Submit a 510(k) for a Change to an Existing Device provides recommendations for evaluating changes to devices …
FDA’s fiscal year (FY) 2027 began on October 1, 2026, at which time the Center for Devices and Radiological Health (CDRH) released its lists of proposed guidance documents it intends to publish or develop during the fiscal year, including: The A-list, which identifies guidance documents CDRH …
On September 21, 2026, the U.S. District Court for the Northern District of Georgia handed the regenerative medicine industry a significant win, vacating two key FDA determinations regarding MiMedx Group, Inc.’s wound-care product AXIOFILL. The decision, MiMedx Group, Inc. v. FDA, No. 1:24-cv-01287 (N.D. Ga. …
On August 18, 2026, FDA’s Center for Devices and Radiological Health (CDRH) released Considerations for the Regulation of Generative AI-Enabled Medical Devices: Discussion Paper and Request for Feedback (Discussion Paper). The paper is not draft or final guidance; rather, it is intended to solicit feedback …
FDA recently released a draft guidance titled Container Closure Systems for Human Drugs and Biological Products. The draft supersedes a 1999 guidance and its 2002 Q&A supplement—documents written before the prevalence of container closure systems (CCSs) like pre-filled syringes, metered dose inhalers, and autoinjectors blurred …
After being announced in April by FDA and CMS, the Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway was released as a proposed procedural notice in the Federal Register on August 11, 2026, and is open for public comment. Comments may be submitted …
On May 29, 2026, FDA issued a final guidance, Content of Human Factors Information in Medical Device Marketing Submissions (Final Guidance), replacing the draft version issued in December 2022 (Draft Guidance). FDA has requested human factors (HF) information in some premarket submissions for years, but …
With the Quality Management System Regulation (QMSR) compliance date of February 2, 2026, FDA has been convening a series of town hall discussions to help industry with compliance. In our previous post we discussed FDA’s final town hall prior to the compliance date and the …
FDA recently issued a Federal Register notice (Docket No. FDA-2026-N-2476) announcing a request for information and comments titled Advancing the Use of Digital Health Technologies in Clinical Investigations for Drugs and Biological Products. A digital health technology (DHT) is a system that uses computing platforms, …
In light of the fast-approaching compliance date of February 2, 2026, FDA convened a town hall discussing last-minute issues governing its priorities for the Quality Management System Regulation (QMSR), which incorporates by reference ISO 13485: 2016 Medical devices — Quality management systems — Requirements for …
FDA has authorized more than 1,200 artificial intelligence (AI)-based digital devices for marketing. To date, none of these has been indicated to address mental health. Currently there are 57.8 million adults who have a diagnosed mental illness and many do not have access to high …
On January 31, 2024, FDA issued the final rule revising 21 C.F.R. Part 820, which, upon taking effect, will be referred to as the Quality Management System Regulation (QMSR) (see our prior blog post here). The QMSR incorporates the international standard ISO 13485: 2016 Medical …
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 …
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 …
