Frequently Reprocessed Single-Use Devices — Draft
Frequently Reprocessed Single-Use Devices — Draft
The Food and Drug Administration is soliciting comments on its proposed list of Frequently Reprocessed Single-Use Devices. (For information on how to send comments, see box, p. 2.) The devices, Code of Federal Regulations (CFR) regulation number, and classification are:
- Surgical Saw Blades: 21 CFR 878.4820, Class I Exempt
- Saw Blades: 21 CFR 878.4800, Class I Exempt
- Surgical Cutting Accessories: 21 CFR 878.4800, Class I Exempt
- Surgical Drills: 21 CFR 878.4820, Class I Exempt
- Surgical Mesh: 21 CFR 878.3300, Class II
- Drill Bits: 21 CFR 878.4540, Class I Exempt
- Laparoscopy Scissors: 21 CFR 876.1500, Class I Exempt
- Endoscopic Carpal Tunnel Blades: 21 CFR 888.4540, Class I Exempt
- Orthodontic (metal) Braces: 21 CFR 872.4510, Class I Exempt
- Orthodontic (plastic) Braces: 21 CFR 872.5470, Class II
- Electrophysiology Catheters: 21 CFR 870.1220, Class II
- Electrosurgical Electrodes and Pencils: 21 CFR 878.4400, Class II
- Cardiac Catheters and Guidewires: Class II and III, 510(k) and PMA; unclassified
- Respiratory Therapy and Anesthesia Breathing Circuits: 21 CFR 868.5240, Class I Exempt
- Biopsy Needles: 21 CFR 878.4800, Class I Exempt; 21 CFR 876.1075, Class II
- Endotracheal Tubes: 21 CFR 868.5730, Class II
- Syringes: 21 CFR 880.5860, Class II
- Sutures: Class II and III, 510(k) and PMA, unclassified
- Staplers: 21 CFR 878.4800, Class I Exempt
- Balloon Angioplasty (PTCA) Catheters: Class II, PMA
- Biopsy Forceps: 21 CFR 876.1075, Class I Exempt, 21 CFR 874.4680, Class II
- Trocars: 21 CFR 874.4420, Class I Exempt, 21 CFR 870.1390, Class II
Source: Food and Drug Administration, Rockville, MD.
Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.