U.S. FDA Medical Device Registration & Listing:
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 United States (U.S.) commercial distribution in the 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. United States (U.S.) All establishments must pay the required U.S. FDA’s Medical Device User Fees.
Docent Pharma Can Assist :
- Medical Device Establishment Registration & Listing
- Medical Device Registration Renewal
- MDUFA User Fees Payment
U.S. FDA Premarket Notification 510(k) Service:
Docent Pharma can assist firm to prepare Traditional, Abbreviated or Special 510(k) submission to FDA.
Our U.S. FDA 510K Submission Service includes:
- Assistance for Identification of Device Class/Product Code/Regulation Number
- Assistance for Identification of Predicate Device
- Assistance for Identification of 510(k) Testing Requirements
- For Identification Testing Service Lab
- Preparation of 510(k) Notification/Document
- Submission of 510(k) Notification/Document to FDA
- Communicate to FDA on behalf of our client/FDA Regulatory Agent
- Assistance in the transfer of MDUFA 510(k) Review Fees to FDA