GMP servicing rules for user facilities recommended in split panel vote.
This article was originally published in The Gray Sheet
Executive Summary
GMP DEVICE SERVICING RULES: APPLICATION TO USER FACILITIES RECOMMENDED by FDA's Device Good Manufacturing Practice Advisory Committee in a five-to-four vote at a Sept. 14 meeting in Gaithersburg, Maryland. The recommendation by a narrow majority to apply the proposed GMP requirements to in-house servicing programs at hospitals and other user facilities came in response to comments from independent servicers, who argued that all servicing entities should be treated equally under the reg.