R
ryno fan
Hello,
1. My understanding of FDA's requirements for Device Listing for medical device manufacturers is to list all Class II and higher devices on FURLS (FDA's Unified Registration and Listing) system; and at least 1 representative Class I device from each device family (classification number and product code). Is this accurate?
2. Is there a requirement for manufacturers to list their marketed medical device accessories?
Thanks for the help.
1. My understanding of FDA's requirements for Device Listing for medical device manufacturers is to list all Class II and higher devices on FURLS (FDA's Unified Registration and Listing) system; and at least 1 representative Class I device from each device family (classification number and product code). Is this accurate?
2. Is there a requirement for manufacturers to list their marketed medical device accessories?
Thanks for the help.