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U.S. FDA Medical Device Master File Requirements

U.S. FDA CITATION: 21 C.F.R. § 814 Subpart B (2016)

A Medical Device Master File (MAF) is a way to preserve trade secrets of medical device companies and their suppliers. A medical device company often needs to submit information about their supplier’s product, facility or process. The MAF allows each company to submit its own confidential data to FDA without it being disclosed to anyone outside FDA. A Medical Device Master File is a submission of information to the U.S. Food and Drug Administration by the Medical Device Master File holder.

A Medical Device Master File is a submission to U.S. FDA that may be used in support of premarket submissions to provide confidential detailed information about establishments, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more medical devices. Registrar Corp’s team of medical device regulatory experts provides guidance as to required elements, formats, and particularities of Medical Device Master File submissions.

Registrar Corp can assist you with the following:

  • FDA Registration, Drug Listing U.S. Agent and Authorizing Official Requirement
  • File a new Medical Device Master File with U.S. FDA
  • Update or Amend an existing Medical Device Master File with U.S. FDA
  • Appoint Registrar Corp as your Agent for U.S. FDA Communications

 

If you would like to file a new Master File (MAF) with U.S. FDA

File a New Medical Device Master File with the U.S. FDA ››


If you already have a MAF number with U.S. FDA
Select one of the following options:

  • Option 1: Update your existing Medical Device Master File with U.S. FDA
    Click the Update button below for any of the following:

    • Amend your Medical Device Master File with U.S. FDA
    • File an Annual Report with U.S. FDA
    • Reactivate a Medical Device Master File with U.S. FDA

Update Information ››

  • Option 2: Order a Certificate of Filing issued by Registrar Corp for your existing Medical Device Master File
    Companies registered with U.S. FDA often are asked by their customers and suppliers to verify their Medical Device Master File filing. A Certificate of Filing issued by Registrar Corp serves to verify your Medical Device Master File

Order a Medical Device Master File Certificate ››





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