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U.S. FDA Medical Device Colostomy Pouch Requirements

FDA Medical Device Definition: An ostomy pouch and accessories is a device that consists of a bag that is attached to the patient's skin by an adhesive material and that is intended for use as a receptacle for collection of fecal material or urine following an ileostomy, colostomy, or ureterostomy (a surgically created opening of the small intestine, large intestine, or the ureter on the surface of the body). This generic type of device and its accessories includes the ostomy pouch, ostomy adhesive, the disposable colostomy appliance, ostomy collector, colostomy pouch, urinary ileostomy bag, urine collecting ureterostomy bag, ostomy drainage bag with adhesive, stomal bag, ostomy protector, and the ostomy size selector, but excludes ostomy pouches which incorporate arsenic-containing compounds.

Registrar Corp assists Colostomy Pouch companies with:

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