Medical devices; reclassification and codification of natural nonabsorbable silk surgical suture--FDA. Final rule.
The Food and Drug Administration (FDA) is announcing the reclassification and codification of natural nonabsorbable silk surgical suture. FDA issued an order in the form of a letter to the manufacturer reclassifying the device from class III (premarket approval) into class II (special controls). Accordingly, FDA is amending the regulations as set forth below.
D000042:Absorption; D004864:Equipment and Supplies / Q000145:classification* / Q000592:standards; D006801:Humans; D011506:Proteins / Q000493:pharmacokinetics; D013537:Sutures / Q000145:classification* / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration