U.S. FDA Medical Device Services

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