The Food and Drug Administration Amendments Act (FDAAA) of 2007 requires that all registration and listing information (Annual, Initial or Updates) be submitted electronically unless FDA grants a waiver.

Owners or operators of establishments or facilities (Domestic/Foreign) that are involved in the production and distribution of medical devices intended for commercial distribution in the United States (U.S.) are required to register/listing with the U.S.FDA.
All device establishments must complete their annual registration for each Fiscal Year between October 1 and December 31.

Note:

All establishments must pay a required U.S. FDA’s Medical Device User Fees.