DEVICE USER FEE APPLICATION "BUNDLING" POLICY WOULD BE PUT IN STATUTE
This article was originally published in The Gray Sheet
Executive SummaryDEVICE USER FEE APPLICATION "BUNDLING" POLICY WOULD BE PUT IN STATUTE under an amendment approved by the House Energy and Commerce Committee during Aug. 9 mark-up of device user fee legislation (HR 4864). Offered by Rep. Sherrod Brown (D-Ohio) at the request of Committee Chairman John Dingell (D-Mich.), the amendment requires FDA to develop guidelines explaining when "a device application which is a combination of multiple device applications" would only be subject to a single application fee.
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