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Assistance with U.S. FDA Medical Device Regulations

The U.S. Food and Drug Administration (FDA) regulates medical devices sold in the USA.  Registrar Corp assists medical device firms with:

  • FDA Registration and Listing Requirements
  • FDA Labeling Requirements
  • UDI and GUDID Requirements
  • Medical Device Master Files (MAF)
  • Release of Detained Shipments
  • and More.

For questions or assistance with FDA medical device regulations, simply complete the form below: