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U.S. FDA Medical Device File Requirements


FDA Medical Device Definition: An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

Registrar Corp assists File companies with:

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