PQE — Ostomy Care Kit Class I
FDA product code PQE covers "Ostomy Care Kit", a Class I medical device regulated under 21 CFR 876.5900. Submissions are reviewed by the Gastroenterology, Urology panel.
Classification Details
- Product Code
- PQE
- Device Class
- Class I
- Regulation Number
- 876.5900
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.