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U.S. FDA Medical Device Burn Sheet Requirements

FDA Medical Device Definition: A burn sheet is a device made of a porous material that is wrapped aroung a burn victim to retain body heat, to absorb wound exudate, and to serve as a barrier against contaminants.

Registrar Corp assists Burn Sheet companies with:

  • FDA Burn Sheet Establishment Registration
  • FDA Burn Sheet Listing
  • FDA Burn Sheet Label Requirements and Exceptions
  • FDA Burn Sheet Import Information
  • FDA Burn Sheet Detentions (Burn Sheet Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Burn Sheet Manufacturers (Burn Sheet Suppliers)
       - Burn Sheet Distributors
       - Burn Sheet Processors
       - Burn Sheet Repackers
       - Burn Sheet Relabelers
       - Burn Sheet Exporters
       - Burn Sheet Importers
For more information about Burn Sheet Medical Devices, simply click below:

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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