2012年 9月 12日
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.