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FDA Will Drop “Cycle” Goals, Prioritize Interactive Device Reviews

This article was originally published in The Gray Sheet

Executive Summary

FDA is proposing to eliminate premarket review interim "cycle" goals in order to prioritize more informal, interactive reviews and final approval decision times under a plan for reauthorization of the medical device user fee program released April 16

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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)

New Interactive FDA Device Review Is Significant, But Goes Only So Far

An FDA staffer trying to create an informal, "interactive review" process for devices warned companies last week that even under the new system they should not expect extensive discussion without temporarily halting review of an application

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