Medical devices; general and plastic surgery devices; classification of absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology. Final rule.
The Food and Drug Administration (FDA) is classifying the absorbable poly(hydroxybutyrate) surgical suture produced by recombinant deoxyribonucleic acid (DNA) technology into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology." The agency is classifying these devices into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of these 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 for this device.
D020341:Absorbable Implants / Q000145:classification*; D004274:DNA, Recombinant; D018795:Device Approval; D004869:Equipment Safety / Q000145:classification; D006801:Humans; D006885:Hydroxybutyrates; D013537:Sutures / Q000145:classification*; D014481:United States; D014486:United States Food and Drug Administration
D004274:DNA, Recombinant; D006885:Hydroxybutyrates