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...
In case you haven't heard... The FDA has issued warning letters to two Chinese firms regarding data quality and integrity concerns. The agency is particularly concerned about the reliability of data used in medical device submissions. As a result, the FDA will not...
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...