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Filing a MAF for Apheresis Immunoadsorption Column with the U.S. FDA


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

  - FENWAL LABORATORIES

Registrar Corp can help you to properly prepare and submit your Apheresis Immunoadsorption Column MAF to FDA.

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

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

For more information about filing a MAF for Apheresis Immunoadsorption Column, 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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