Beyond the 510(k): Why "GMP-Exempt" Status Matters in Medical Device Classification Navigating the world of medical device regulation can feel like deciphering a complex code. You're likely familiar with device classes (Class I, II, and III) and submission types like...
Data Integrity Crackdown: FDA Tightens Oversight on Third-Party Lab Testing Medical device manufacturers received a serious wake-up call this year: the FDA is rejecting study data from two Chinese labs after uncovering widespread data integrity violations. The message...