On October 22, 2026, the DOJ Civil Division and the Department of Health and Human Services (HHS) announced a six-month pilot program that offers “legitimate American healthcare businesses” a defined path to come clean on potential False Claims Act (FCA) violations, in exchange for a …
Yes, we know — the O.N. Diagnostics Warning Letter has already been thoroughly covered since FDA posted it on October 6. We waited for the dust to settle, since we think software companies will be living with the implications of this letter for quite some …
On October 1, 2026, FDA’s 2027 fiscal year began and with it the renewal period for device establishment registrations. Companies have until December 31, 2026, to pay the annual registration fee ($13,785), review their current registration information and device listings, and make any necessary updates …
FDA’s fiscal year (FY) 2027 began on October 1, 2026, at which time the Center for Devices and Radiological Health (CDRH) released its lists of proposed guidance documents it intends to publish or develop during the fiscal year, including: The A-list, which identifies guidance documents CDRH …
On October 14, 2026, HHS Secretary Robert F. Kennedy, Jr. formally delegated to the CMS Administrator the Secretary’s permissive exclusion authority under Section 1128(b) of the Social Security Act, effective immediately. See Federal Register Notice here. Section 1128(b) allows the government to prohibit companies and …
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FDA recently released a draft guidance titled Container Closure Systems for Human Drugs and Biological Products.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 …
