US suture makers face product risk regrading
This article was originally published in Clinica
Executive Summary
Manufacturers of eight categories of surgical sutures must conform with new performance, testing and labelling recommendations as of July 3, the FDA has announced. All of the sutures were on the market when the agency first obtained regulatory authority over devices in 1976, and as such were put in a transitional class III (high-risk) category until the FDA could decide on their appropriate classification.
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