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U.S. FDA Medical Device Ostomy Pouch & Accessories 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 Pouch & Accessories companies with:

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