HR 8890 would keep LDT oversight with CMS under CLIA and add a public validation database, serious harm reporting, and optional third-party review.
2025 FDA Warning Letter Trends
FDA warning letters in the first half of 2025 highlight recurring issues with Medical Device Reporting and complaint handling. From missing procedures to delayed submissions, the same preventable mistakes appear again and again putting companies at risk.
Your Data, Your Responsibility
Update, August 2026: A third lab, and a distinction worth understanding On June 25, 2025, FDA issued a Good Laboratory Practice warning letter to CCIC Huatongwei International Inspection Co., Ltd. in Suzhou, China, following a January 2025 inspection. The findings...
Warning Letters
Update: This post was written in October 2024 when FDA first announced the action. FDA has since gone further, rejecting all study data from both facilities, and we have written a fuller piece on what this means for your supplier qualification program. For the current...
Devices are Trending
In recent years, a significant trend has been emerging in the healthcare landscape. Medical devices, traditionally seen as secondary tools or adjuncts to therapeutic interventions, are increasingly becoming primary treatments for conditions that were once managed...