FDAnews Device Daily Bulletin
Medical Devices / Postmarket Safety

Public Workshop on Third-Party Refurbishing of Devices Slated for October

July 26, 2016

The FDA is holding a public workshop Oct. 27 to Oct. 28 to discuss stakeholder input on refurbishing and reconditioning medical devices by third parties.

 The agency had sought public comments on the challenges third-party entities face in maintaining or restoring devices to their original or current specifications.

The FDA said the request for comments was prompted by stakeholder concerns that some third-party entities may use unqualified personnel to perform service, maintenance, refurbishment and device alterations on their equipment and that the work may not be adequately documented. — Tamra Sami

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