Sep 12, 2012
The US Food and Drug Administration has published a list of frequently asked questions regarding new medical device registration and listing requirements that go into effect October 1, 2012.
Key changes covered in the FDA FAQ include:
Registrants must also inform the FDA of all current proprietary and white-label names of their devices, as well as use lists in the FDA Unified Registration and Listing System (FURLS) in order to identify combination products with both medical device and biological or pharmaceutical components.
All medical device manufacturers currently marketing their products or considering commercialization in the US should take into account these upcoming changes to determine how their existing or future FDA medical device registrations will be impacted.
A new study sponsored by the US medical device industry trade association Advanced Medical Technology Association (AdvaMed), “EU Medical Device Approval Safety Assessment,” has found that the European regulatory system has performed just as effectively in terms of public safety as the US Food and Drug Administration while simultaneously providing a speedier and more efficient path to market for manufacturers.
Through new guidance published this month, the US Food and Drug Administration has clarified its review and approval process for its Investigational Device Exemption (IDE) regulations, and has also proposed steps to allow clinical investigations of high-risk medical devices in some instances where IDE approvals have not been finalized.