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U.S. FDA Medical Device Arm Sling Requirements

FDA Medical Device Definition: An arm sling is a device intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.

Registrar Corp assists Arm Sling companies with:

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