Frequently Reprocessed Single-Use Devices — Draft
January 1, 2000 2 minutes read
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.
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