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In Brief: Reprocessed single-use devices

This article was originally published in The Gray Sheet

Executive Summary

Reprocessed single-use devices: Firms that reprocess single-use devices for multiple use will not at present be required to submit 510(k)s for the products to FDA, according to Kim Trautman, quality systems expert in the Center for Devices and Radiological Health. Speaking at an Oct. 25 Health Industry Manufacturers Association meeting in Washington, D.C., Trautman says FDA will exercise "regulatory discretion" by not requiring submissions for reprocessed disposables. CDRH Director Bruce Burlington believes "the agency needs to do more information gathering" before a final policy can be determined. A CDRH working group was formed earlier this year to draft a policy on the issue ("The Gray Sheet" April 22, I&W-3)...
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