Medical devices; designation of special control for eight surgical suture devices. Final rule.
The Food and Drug Administration (FDA) is issuing a final rule to amend the classification regulations for eight surgical suture devices previously reclassified into class II to specify a special control for those devices. The special control is an FDA guidance document entitled "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA" that identifies performance, testing, and labeling recommendations for the devices. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control. FDA is taking these actions on its own initiative because it believes they are necessary to provide reasonable assurance of the safety and effectiveness of surgical suture devices. These actions are being taken under the Federal Food, Drug, and Cosmetic Act (the act).
D018795:Device Approval; D004869:Equipment Safety; D006801:Humans; D013525:Surgical Instruments / Q000145:classification*; D013537:Sutures / Q000145:classification*; D014481:United States; D014486:United States Food and Drug Administration