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U.S. FDA Medical Device Homemaking Utensil 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 Homemaking Utensil companies with:

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