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In Brief: IMDMC petition

This article was originally published in The Gray Sheet

Executive Summary

IMDMC petition: Rep. David McIntosh (R-Ind.) urges FDA "to move forward" on a response to the Indiana Medical Device Manufacturers Council's May 1995 citizens petition on the agency's use of guidance documents ("The Gray Sheet" May 22, 1995, p. 3). In an Aug. 6 letter to FDA Deputy Commissioner for Policy William Schultz, the Indiana Republican notes that "it has been well over a year" since the trade group submitted its petition and recommends FDA "set a completion date" for the response. In addition, McIntosh asks for a status report on the IMDMC issue, "an outline for FDA's future plan for developing a response to the petition," and a "summary of the anticipated form(s) of FDA's response to the full range of rulemaking and guidance issues raised by the petition." FDA has proposed a series of "good guidance practices" to address several of the issues in the petition ("The Gray Sheet" March 11, I&W-2); the agency hopes to finalize the GGPs before the end of the year. FDA's device center has implemented its own guidance policy until the agency-wide GGPs are completed...

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