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 response to what FDA calls “inadequate responses to FDA 483 observations due to a lack or omission of relevant data, excessive amounts of data, and/or failure to address the root cause of observations,” the Agency published a new Draft Guidance on Responding to FDA …
Hyman, Phelps & McNamara, P.C. (HPM) is hosting a complimentary webinar, titled “From Prototype to Approval: US Regulatory Strategy for MedTech Startups.” The webinar is scheduled for March 25, 2026 (11:00am to 12:00pm ET). Bringing a medical device from prototype to market requires more than innovation—it …
The American Conference Institute’s (“ACI”) FDA Boot Camp returns March 25-26, 2026, at the New York City Bar, New York, NY. This foundational training brings together life sciences attorneys, in-house counsel, and compliance professionals to dissect FDA law, policy, and enforcement trends. What You’ll Gain: A clear …
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 …
Artificial Intelligence (“AI”) in the life sciences has moved from pilot to production, across discovery, trials, and post-market. With the EU AI Act taking effect, evolving FDA expectations, and looming litigation and enforcement risk, getting it right has never mattered more. Join the American Conference Institute …
On January 6, 2026, FDA issued two revised guidance documents related to clinical decision support (CDS) software and low-risk general wellness products. In a video announcing the revised guidance documents, Commissioner Makary states that they are intended to “cut unnecessary regulation and promote innovation” in …
On December 16, CDRH issued 12 Warning Letters to manufacturers and retailers of breast binders. The Warning Letters were posted on FDA’s website 2 days later. According to the Warning Letters, the products offered by these companies are intended to compress breast tissue and create …
FDA wants to capitalize on the talent of venture capital (VC) firms that are developing innovative solutions that can be applied to FDA’s public health mission. On December 17, 2025, FDA issued a Request for Information (RFI) for its FIRE program, which stands for “Foundational …
On December 8, 2025, the Government Accountability Office (GAO) sent a report to Senators Richard Durbin and Richard Blumenthal in response to the Senators’ request for GAO to review FDA’s medical device recall process. At a high level, the findings are not surprising—FDA’s staffing is …
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 …
At this point in 2024, there were countless unknowns about how the medical device industry would be impacted in 2025. Did the year unfold as you expected? Did your company prepare for impacts to the foreign supply chain? Did you predict the government was going …
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 …
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 …
Hyman, Phelps & McNamara, P.C. (HPM) is hosting a complimentary webinar, titled “Medical Device Update, 2025 Year in Review.” The webinar is scheduled for December 10, 2025 (11:00am to 12:00pm ET). Don’t miss this essential briefing. Our experts will unpack the year’s top FDA regulatory changes, …
