For the third time in this Administration, DOJ is directing its prosecutors to “take an aggressive, all-tools approach to investigating and prosecuting” certain categories of fraud. Unfortunately, the health care and life sciences space has been singled out, and remains solidly in the crosshairs for …
On August 31, 2026, FDA and the Securities and Exchange Commission (SEC) announced a new Memorandum of Understanding (MOU) intended to enhance cooperation between the agencies and facilitate the exchange of non-public information relevant to their respective oversight and enforcement responsibilities. The agreement runs for …
On August 18, 2026, FDA’s Center for Devices and Radiological Health (CDRH) released Considerations for the Regulation of Generative AI-Enabled Medical Devices: Discussion Paper and Request for Feedback (Discussion Paper). The paper is not draft or final guidance; rather, it is intended to solicit feedback …
FDA recently released a draft guidance titled Container Closure Systems for Human Drugs and Biological Products. The draft supersedes a 1999 guidance and its 2002 Q&A supplement—documents written before the prevalence of container closure systems (CCSs) like pre-filled syringes, metered dose inhalers, and autoinjectors blurred …
After being announced in April by FDA and CMS, the Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway was released as a proposed procedural notice in the Federal Register on August 11, 2026, and is open for public comment. Comments may be submitted …
CDRH’s September 25 public meeting offers a front-row seat to the science shaping the future of medical device review. Last week, the FDA’s Center for Devices and Radiological Health (CDRH) announced a public meeting titled “Regulatory Science Innovations Catalyzing Medical Device Development,” scheduled for September 25, …
Last week FDA publicly posted the first Quality Management System Regulation (QMSR) Warning Letter and this week it posted the second. The QMSR went into effect in February of this year. For months, we have seen the top 483 citations shift in FDA’s inspection database …
On July 20, 2026, FDA posted a funding opportunity for sponsors putting digital health technologies (DHTs) to work in clinical trials. RFA-FD-26-012 is a U01 cooperative agreement with a $1.1 million award ceiling, two expected awards, and no cost-sharing requirement (Assistance Listing 93.103). Applications close …
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 …
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 …
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 …
