An owner or operator of an establishment who is engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of a device intended for human use is generally required to register the establishment and submit listing information for all devices in commercial distribution.
Under section 510(k) of the FD&C Act, each person who is required to register their establishment must generally submit a 510(k) to FDA at least 90 days before proposing to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a device intended for human use if the device is being introduced into commercial distribution for the first time.
Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers