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Filing a MAF for Analyser with the U.S. FDA

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


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

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

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

For more information about filing a MAF for Analyser, 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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