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U.S. FDA Medical Device Hygiene Adaptor 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 Hygiene Adaptor companies with:

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