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More MDUFMA Guidance: FDA Clarifies Performance Goal Review Clock Rules

This article was originally published in The Gray Sheet

Executive Summary

FDA will grant PMA sponsors an extension of up to 180 days to respond to major deficiencies, the agency notes in a guidance outlining various device review actions and their impact on FDA fulfillment of user fee performance goals

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Regulatory News In Brief

Updated FDA review clock guidance: Agency issues June 30 1guidance detailing the different actions FDA may take on pre-market approval applications and clarifying FDA's timeline goals for applications filed from FY 2008-2012 versus those filed from FY 2003-2007. The 2007 FDA Amendments Act removed interim cycle goals, which often stopped the "review clock" and inadvertently prolonged the review process, maintaining FDA decision goals only. FDA will follow the review goals proposed as part of the new user fee legislation (2"The Gray Sheet" April 23, 2007, p. 7). Cycle goals are also abolished for applications filed in FY 2007. Performance goals will no longer vary from year to year, and FDA now has the option of issuing major deficiency letters for 180-day supplements, as well as for PMAs and panel-track supplements, the guidance points out. The document replaces October 2003 guidance based on the review clock in the 2002 user fee legislation (3"The Gray Sheet" Oct. 13, 2003, p. 22)

Regulatory News In Brief

Updated FDA review clock guidance: Agency issues June 30 1guidance detailing the different actions FDA may take on pre-market approval applications and clarifying FDA's timeline goals for applications filed from FY 2008-2012 versus those filed from FY 2003-2007. The 2007 FDA Amendments Act removed interim cycle goals, which often stopped the "review clock" and inadvertently prolonged the review process, maintaining FDA decision goals only. FDA will follow the review goals proposed as part of the new user fee legislation (2"The Gray Sheet" April 23, 2007, p. 7). Cycle goals are also abolished for applications filed in FY 2007. Performance goals will no longer vary from year to year, and FDA now has the option of issuing major deficiency letters for 180-day supplements, as well as for PMAs and panel-track supplements, the guidance points out. The document replaces October 2003 guidance based on the review clock in the 2002 user fee legislation (3"The Gray Sheet" Oct. 13, 2003, p. 22)

FDA Clarifies 510(k) Review Clock Policy In MDUFMA Guidance

FDA will allow extensions of up to 90 days for firms to respond to additional information (AI) requests, the agency explains in a guidance document on 510(k) user fee performance goals

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