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...
How to Complete FDA Annual Facility Registration: A Step-by-Step Overview This video highlights the step-by-step process for completing the FDA annual facility registration, a mandatory requirement for medical device businesses operating under FDA jurisdiction. The...
FDA Cracks Down on Unreliable Lab Data: What Device Firms Need to Know 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 and the message...
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...