www.fdanews.com/articles/177671-public-workshop-on-third-party-refurbishing-of-devices-slated-for-october
Public Workshop on Third-Party Refurbishing of Devices Slated for October
July 25, 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