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U.S. FDA Medical Device Ostomy Protector 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 Ostomy Protector companies with:

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