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Surgical Sutures To Be Class II With Special Controls Under Proposed Rule

This article was originally published in The Gray Sheet

Executive Summary

Comments on an FDA guidance outlining special controls for eight Class II surgical sutures are due March 19, 2003

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Surgical suture guidelines

Special controls final guidance for absorbable polydioxanone (PDS) surgical sutures also will serve as guidance for eight other sutures reclassified into Class II with special controls in a 1suture final rule that takes effect July 3. The 2suture guidance supersedes a Dec. 19, 2002 document (3"The Gray Sheet" Dec. 23, 2002, p. 22)...

Surgical suture guidelines

Special controls final guidance for absorbable polydioxanone (PDS) surgical sutures also will serve as guidance for eight other sutures reclassified into Class II with special controls in a 1suture final rule that takes effect July 3. The 2suture guidance supersedes a Dec. 19, 2002 document (3"The Gray Sheet" Dec. 23, 2002, p. 22)...

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Sponsors of resorbable suture 510(k)s should include a resorption profile based on in vivo or in vitro studies that illustrates the tensile strength of the suture for a clinically significant period of time, depending on the suture's intended use, guidance issued Aug. 10 advises

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