Scholar Rock's SMA drug was rejected over a facility inspection finding. The fix wasn't fixing the facility — it was building a redundant one.

FDA's advisory panel split 6-4 on Galleri's effectiveness in the first-ever MCED test PMA review. Here's why the vote diverged and what it means next.

How FDA assigns drug-device, biologic-device, and drug-biologic combination products to CDER, CBER, or CDRH: primary mode of action, the Request for Designation process, and how sponsors should plan around jurisdiction early.

QMSR removed the exemption that long kept supplier audit records out of FDA investigators' reach. What that means for supplier and outsourcing controls under ISO 13485, and how to get supplier audit files inspection-ready.

The UK's draft International Reliance pathway would let device manufacturers build on approvals from trusted regulators such as FDA, TGA, and Health Canada to reach the Great Britain market faster. What's proposed, what's confirmed, and how to plan multi-market strategy.

QMSR replaced the QSR on February 2, 2026, incorporating ISO 13485:2016 by reference. What actually changed for device manufacturers, what stayed the same, and what FDA investigators are finding in the first months of inspections.

Breakthrough Device Designation by the numbers: how many designations FDA has granted, how few have reached marketing authorization, and what the program actually changes for sponsors beyond the headline.

CAPA deficiencies remain one of FDA's most reliable predictors of enforcement. What separating corrective and preventive action workflows looks like under QMSR, and what manufacturers actually need to change in their quality systems.

How Predetermined Change Control Plans let AI/ML-enabled device makers pre-authorize specific model updates without a new marketing submission, what FDA expects a PCCP to contain, and how PCCPs are reshaping AI device regulatory strategy.

FDA's December 2025 final guidance on real-world evidence for medical devices removed a major barrier to using real-world data in submissions. What changed in 2026, and what device sponsors need to do differently to put RWE to work.

MDUFA VI will reset review timelines, staffing, and user fees for every device company working with FDA from fiscal 2028 through 2032. What the draft commitment letter changes, and what device sponsors should do now.

FDA's Digital Health Center of Excellence has published a discussion paper on regulating generative AI-enabled medical devices, posing 26 detailed questions with a public comment docket open through October 19. What it signals about where FDA's thinking is headed, and how sponsors should respond.

On August 5, FDA held a public meeting to walk through its proposed recommendations for reauthorizing the Medical Device User Fee Amendments — MDUFA VI — the negotiated agreement that will determine how FDA's device review program is funded and how fast it moves for fiscal years 2028 through 2032. That meeting matters because of what preceded it: FDA and industry, represented by AdvaMed and the Medical Device Manufacturers Association, had already reached an agreement in prin

FDA's voluntary Quality Management Maturity Program is quietly building toward a real quality rating system. Here's what it measures and what's at stake.

FDA decides Aug 5 on Moderna's mRNA-1010 flu vaccine. Here's the trial data, the competitive landscape, and why the decision matters beyond flu shots.

FDA retired QSIT, its 30-year device inspection framework, on Feb 2, 2026. Here's what the new QMSR-aligned, risk-based process means for your audits.

FDA's final Human Factors guidance takes effect this week. Here's what changed in the eSTAR template and what to check in your submission pipeline now.

In February 2008, hospitals across the United States began seeing something that almost never happens with heparin, a blood thinner used in millions of procedures every year: patients going into sudden, severe allergic-type reactions — hypotension, nausea, shortness of breath — within minutes of receiving it. The FDA would eventually trace the cause to a contaminant called oversulfated chondroitin sulfate, added somewhere upstream in the crude heparin supply chain in China, a

For thirty years, "checking MAUDE" has been shorthand for post-market vigilance in the medical device industry. It is the database regulatory teams cite in literature searches, the tool clinical affairs pulls up before a submission, the first stop for anyone trying to understand how a device is behaving once it leaves the controlled world of a clinical trial and enters the far messier world of actual patients. By the end of May 2026, it will not exist in its current form.