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U.S. FDA Medical Device Operating-Room Shoes Requirements

FDA Medical Device Definition: Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.

Registrar Corp assists Operating-Room Shoes companies with:

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