On December 5, FDA’s Digital Health Center of Excellence announced the “Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot,” in conjunction with the Center for Medicare and Medicaid Innovation (CMMI) Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model. FDA’s press release states …
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 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, …
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 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 …
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 …
At the end of June, HHS Secretary Robert F. Kennedy told a House congressional committee that he would like to see all Americans make use of wearable products, such as Apple Watch, Oura Rings, Fitbits, and WHOOP, to “take control of their health.” Less than …
We have written many posts (here, here, here, and more) about the impact of the reductions in force (RIFs) on various activities across FDA. One area where the RIFs are beginning to have an impact is with respect to Small Business Determination (SBD) requests submitted …
Last week, FDA published a Request for Information (RFI) (here) seeking input from the public on its efforts to “to identify and eliminate outdated or unnecessary regulations.” The Announcement raises several questions and issues for the device industry. 10-for-1 Rule and its effect on de novos. …
On Thursday, November 14, President-Elect Trump announced his pick of Robert Kennedy, Jr., for Secretary of Health and Human Services (HHS). Although not altogether surprising, the formality of an official announcement still came as a shock to many of us who work in areas regulated …
“An open foe may prove a curse, but a pretended friend is worse.” When the poet John Gay wrote these words in 1727, the idea of an administrative agency like the FDA was likely the furthest thing from his mind. That he is now being …
Though digital health is not new, it can still often be difficult to determine with precision the regulatory requirements applicable to a particular software product. Sometimes this is because FDA has not opined on a specific set of facts, but more often it is because …
We can all acknowledge that the title of this post is not that funny-at least, not to anyone other than medical device regulatory nerds, such as the author of this post. What no one should find funny is how CDRH seems to be approaching Breakthrough …
In November 2023, FDA published a proposed rule regarding wound products containing antimicrobials. From a legal perspective, the reason for the proposed rule is that these wound products are some of the few remaining medical devices that have not yet been classified by FDA. As …
