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U.S. FDA Medical Device Template Requirements

FDA Medical Device Definition: A template for clinical use is a device that consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.

Registrar Corp assists Template companies with:

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