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Filing a MAF for 3% Sodium Hyaluronate with the U.S. FDA


Filing a medical device master file (MAF) for 3% Sodium Hyaluronate can be a useful mechanism to market your 3% Sodium Hyaluronate to the U.S. Medical Device Industry. Typical 3% Sodium Hyaluronate producers who have filed a MAF for 3% Sodium Hyaluronate include:

  - LIFECORE BIOMEDICAL INC.

Registrar Corp can help you to properly prepare and submit your 3% Sodium Hyaluronate MAF to FDA.

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

  - Ensure administrative accuracy of your 3% Sodium Hyaluronate MAF
  - Format, assemble and deliver your 3% Sodium Hyaluronate MAF to FDA
  - Assist with preparing letters of authorization regarding your 3% Sodium Hyaluronate MAF
 - Provide changes, additions and maintenance of your 3% Sodium Hyaluronate MAF
  - Respond to issues relating to ownership of your 3% Sodium Hyaluronate MAF
  - Assist with submission of responses to FDA concerning your 3% Sodium Hyaluronate MAF

For more information about filing a MAF for 3% Sodium Hyaluronate, 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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