On June 15, 2026, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Happiest Baby, Inc., the manufacturer of the SNOO Smart Sleeper bassinet system, following a July 2025 inspection of the company’s Los Angeles facility. The Warning Letter highlights several key …
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in Medical Device Marketing Submissions (Final Guidance), replacing the draft version issued in December 2022 (Draft Guidance).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 …
Parallel review. Medicare Coverage of Innovative Technology (MCIT). Transitional Coverage for Emerging Technologies (TCET). Each of these initiatives promised to close the persistent gap between FDA marketing authorization and CMS coverage for medical devices. None has fully delivered. Some were formally withdrawn; others simply faded …
On April 7, 2026, FDA’s Center for Devices and Radiological Health (CDRH) announced the READI-Home Innovation Challenge: Reducing Readmissions through Device Innovation for the Home, part of its broader Home as a Health Care Hub initiative. The program is intended to accelerate patient access to …
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 …
On April 22 and 23, 2026, the Association of Medical Diagnostic Manufacturers will hold its Annual Meeting at the Canopy by Hilton in Bethesda, MD. The day and a half meeting, which is preceded by the group’s annual IVD 510(k) conference will be kicked off …
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data, excessive amounts of data, and/or failure to address the root cause of observations,” the Agency published a new Draft Guidance on Responding to FDA …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 …
