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U.S. FDA Medical Device Surgical Bit Requirements

FDA Medical Device Definition: instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

Registrar Corp assists Surgical Bit companies with:

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