Device software policy revisions via negotiated rulemaking under consideration by FDA.
This article was originally published in The Gray Sheet
Executive SummaryDEVICE SOFTWARE POLICY DEVELOPMENT VIA NEGOTIATED RULEMAKING is one option under review by FDA, Harvey Rudolph, acting Deputy Director of the Office of Science and Technology in FDA's Center for Devices and Radiological Health, said at a Dec. 11 Food and Drug Law Institute meeting in Washington, D.C. If "there are some details that we can't deal with except through an arbitration process," the agency could pursue negotiated rulemaking to "come out with something which is...a true consensus," Rudolph suggested.
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