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in Medical Device Marketing Submissions (Final Guidance), replacing the draft version issued in December 2022 (Draft Guidance).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 …
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 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 …
On May 8, 2025, FDA announced the successful completion of a generative artificial intelligence (AI) scientific review pilot program aimed at accelerating the review process and an “aggressive” timeline to rollout the use of AI tools across the Agency. Extolling the “tremendous promise” of the …
Last year, FDA issued a letter to the medical device industry warning medical device firms of concerns related to fraudulent and unreliable laboratory testing data in premarket submissions, which we blogged about here. This was followed last September with warning letters issued to two Chinese …
In the past three months, FDA has released two guidance documents related to artificial intelligence (AI) enabled medical devices: (1) a final guidance titled Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions (PCCP Guidance, which we blogged about …
In early January, FDA released a draft guidance document titled Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (Draft AI Guidance). FDA has issued discussion papers (see our posts here and here ) and guidance on use of Pre-determined Change Control Plans …
