U.S. FDA Medical Device Colostomy Appliance 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.
FDA Colostomy Appliance Establishment Registration
FDA Colostomy Appliance Listing
FDA Colostomy Appliance Label Requirements and Exceptions
FDA Colostomy Appliance Import Information
FDA Colostomy Appliance Detentions (Colostomy Appliance Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Colostomy Appliance Manufacturers (Colostomy Appliance Suppliers)
- Colostomy Appliance Distributors
- Colostomy Appliance Processors
- Colostomy Appliance Repackers
- Colostomy Appliance Relabelers
- Colostomy Appliance Exporters
- Colostomy Appliance Importers
For more information about Colostomy Appliance Medical Devices, simply click below:
U.S. FDA Regulations:
U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.
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