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U.S. FDA Medical Device Non-Electric Biopsy Forceps Requirements


FDA Medical Device Definition: A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Registrar Corp assists Non-Electric Biopsy Forceps companies with:

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