FDA closed out 2025 - and opened the door to 2026 - with a clear signal to digital health and medical device sponsors: real-world performance of digital technologies is no longer a future consideration, it’s [...]
Across medical device and IVD inspections, U.S. Food and Drug Administration (FDA) continues to issue Form 483 observations and Warning Letters tied to risk management failures. These findings are not about missing templates, they reflect [...]
FDA closed out 2025 with a meaningful update for device sponsors: the final guidance, “Use of Real-World Evidence (RWE) to Support Regulatory Decision-Making for Medical Devices,” issued December 18, 2025, which supersedes the prior 2017 [...]
With the February 2, 2026, implementation date for FDA’s Quality Management System Regulation (QMSR) quickly approaching, FDA has now issued a final rule making 179 technical amendments across Title 21 of the Code of Federal Regulations. These updates formally replace legacy Quality System Regulation (QSR) references with QMSR terminology throughout [...]
If you want to know where regulatory expectations are headed, you don’t always need a new guidance document. Sometimes you just need to listen to what regulatory pros keep arguing about. Across recent discussions, three themes keep surfacing again and again: How long to keep records in a world of [...]
The U.S. government shutdown has finally ended, and for the FDA, the relief is real. With Congress passing a funding bill covering the agency through September 30 of the next fiscal year, the agency now enjoys a measure of stability that reduces the risk of future funding lapses. But that [...]
The FDA’s updated guidance on Unique Device Identification (UDI) for combination products, updated as of June 2025, has stirred conversation across the industry. For companies developing products that merge drug, biologic, and device components, labeling has always been a regulatory gray zone. Now, the FDA’s latest updates, intended to clarify [...]
The start of October 2025 brought an unusual complication for the life sciences industry - a partial U.S. government shutdown that has significantly limited FDA operations. With much of the agency’s staff on furlough and access to key resources frozen, the FDA has announced that it will not accept or [...]
Starting today, October 6th, and ending on October 7th, regulatory professionals from around the world will gather in Pittsburgh, Pennsylvania for RAPS Convergence 2025, the go-to conference for insights, networking, and future-focused discussions in medical devices, pharma, diagnostics, and more. Pre-conference workshops will take place on October 6 and 7, [...]
