If you have already paid the establishment registration fee and have your Payment Identification Number (PIN) and Payment Confirmation Number (PCN), use the link below to access the electronic registration and listing system:
Public reporting burden for this collection of information on form FDA 3673, used to register and list in the electronic system, is estimated to be 0.50 hours per response for the purpose of firms annually registering their establishment and 0.25 hours per response for the purpose of firms annually listing their devices. These estimates are based on FDA's experience, data from the device registration and listing database, and our estimates of the time needed to complete other previously required forms.
Send comments regarding this burden estimate or another aspect of this collection of information, including suggestions for reducing this burden to:
Office of Information Management,
Food and Drug Administration,
10903 New Hampshire Avenue
Silver Spring, MD 20993