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U.S. FDA Medical Device Disposable Hot or Cold Pack Requirements


FDA Medical Device Definition: A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces

Registrar Corp assists Disposable Hot or Cold Pack companies with:

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