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U.S. FDA Medical Device Transfer Aid Requirements

FDA Medical Device Definition: A daily activity assist device is a modified adaptor or utensil (e.g., a dressing, grooming, recreational activity, transfer, eating, or homemaking aid) that is intended for medical purposes to assist a patient to perform a specific function.

Registrar Corp assists Transfer Aid companies with:

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