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.