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U.S. FDA Medical Device Caliper Requirements

FDA Medical Device Definition: A caliper for clinical use is a compass-like device intended for use in measuring the thickness or diameter of a part of the body or the distance between two body surfaces, such as for measuring an excised skeletal specimen to determine the proper replacement size of a prosthesis.

Registrar Corp assists Caliper companies with:

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