User facility exemption from revised GMP service rules sought by AHA, AAMI.
This article was originally published in The Gray Sheet
Executive Summary
VOLUNTARY DEVICE SERVICER GUIDELINES INSTEAD OF GMP RULES are advocated by the International Association of Medical Equipment Remarketers in comments on FDA's latest draft of proposed revisions to device good manufacturing practices regulations. Stressing the group's "vigorous opposition" to FDA's proposal to extend GMP requirements to third-party servicers, IAMER instead supports "the development of a set of voluntary guidelines specifically designed to address specific service, refurbishment and installation issues as they apply to various medical equipment specialties."