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Filing a MAF for Acetabular Cup with the U.S. FDA


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

  - DEPUY ORTHOPAEDICS INC.
  - MASSACHUSETTS GENERAL HOSPITAL

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

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

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

For more information about filing a MAF for Acetabular Cup, 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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