Zdrowie i gospodarka · 19/12/2002

Medical Devices; Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA; Availability

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA." This guidance will serve as a special control for the absorbable polydioxanone surgical (PDS) suture which is being reclassified from class III to class II (special controls) elsewhere in this issue of the Federal Register. This guidance document is immediately in effect as the special control for the absorbable PDS suture, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs). Also, elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to amend eight other surgical suture device classification regulations in order to designate this guidance as the special control for each such device. After public comments are reviewed, FDA intends to issue a final rule for the eight other surgical sutures and make this guidance effective as the special control guidance for those sutures in addition to the PDS suture, for a total of nine suture types. This guidance is not final nor is it in effect at this time for the eight surgical suture