FDA Classifies Some Surgical Sutures as Class II

The FDA has issued a guidance supporting the classification of absorbable poly(hydroxybutyrate) surgical sutures produced by recombinant DNA technology into Class II — special controls.

These sutures are made of material isolated from prokaryotic cells produced by recombinant DNA technology and are intended for use in general soft tissue approximation and ligation.

The guidance gives the agency’s recommendations for preparing abbreviated 510(k) applications for these devices and is issued in conjunction with a Federal Register notice announcing the classification of the devices.

The guidance, “Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology,” can be found at www.fda.gov/OHRMS/DOCKETS/
98fr/07d-0268-gdl0001.pdf.