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U.S. FDA Medical Device Moist Heat Pack Requirements

FDA Medical Device Definition: A moist heat pack is a device intended for medical purposes that consists of silica gel in a fabric container used to retain an elevated temperature and that provides moist heat therapy for body surfaces.

Registrar Corp assists Moist Heat Pack companies with:

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