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Filing a MAF for Antimicrobial Products with the U.S. FDA


Filing a medical device master file (MAF) for Antimicrobial Products can be a useful mechanism to market your Antimicrobial Products to the U.S. Medical Device Industry. Typical Antimicrobial Products producers who have filed a MAF for Antimicrobial Products include:

  - EASTMAN KODAK COMPANY

Registrar Corp can help you to properly prepare and submit your Antimicrobial Products MAF to FDA.

As your Agent, Registrar Corp will perform the following administrative functions:

  - Ensure administrative accuracy of your Antimicrobial Products MAF
  - Format, assemble and deliver your Antimicrobial Products MAF to FDA
  - Assist with preparing letters of authorization regarding your Antimicrobial Products MAF
 - Provide changes, additions and maintenance of your Antimicrobial Products MAF
  - Respond to issues relating to ownership of your Antimicrobial Products MAF
  - Assist with submission of responses to FDA concerning your Antimicrobial Products MAF

For more information about filing a MAF for Antimicrobial Products, simply click below:




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U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.


Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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