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U.S. FDA Medical Device Surgical File Requirements

FDA Medical Device Definition: A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

Registrar Corp assists Surgical File companies with:

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