This third installment of our series analyzing the rider provisions in the fiscal year 2026 appropriations legislation continues our examination of key FDA policy directives embedded in congressional committee reports. This post focuses on provisions related to medical devices, pharmacy compounding, GLP-1 medications, and food-areas …
This is the second in our series analyzing the riders attached to the FY 2026 Labor-HHS Appropriations Bill. This installment examines the drug-related provisions, which cover a wide range of topics from accelerated approval and rare disease therapies to biosimilars and opioid regulation. The Committee’s …
On May 1, 2026, the House Committee on Appropriations submitted House Report 119-632 to accompany H.R. 8646—the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for Fiscal Year 2027, which passed on June 4, 2026. The report serves as the Committee’s …
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 …
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 Some were formally withdrawn; others simply faded …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 …
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 …
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 …
