Federal Register Final rule: FDA is classifying the absorbable poly(hydroxybutyrate) surgical suture produced by recombinant deoxyribonucleic acid (DNA) technology into Class 2 (special controls) with the guidance, Class 2 Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology serving as the special control. To download the guidance document, click here. To view this final rule, click here.
