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Device Center Quality Initiative Seeks Improved PMA Filing Process

This article was originally published in The Gray Sheet

Executive Summary

CDRH will draw on a study of its PMA filing process in drafting guidance on application filing criteria intended to aid implementation of the Medical Device User Fee & Modernization Act, staffers say

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Regulatory News In Brief

Modular PMA policy tied to user fee shortfall: CDRH's decision to exempt modular PMAs from user fees if the first module was submitted prior to Oct. 1, 2002 resulted in higher PMA costs for fiscal 2004, Director David Feigal tells attendees during the Regulatory Affairs Professionals Society's annual meeting in Baltimore Oct. 19-22. "Had we made the opposite decision on modular 510(k)s, we would have hit the [FY 2003] fees right on the nose," he notes. "One of the reasons we didn't raise $25 mil. and only raised $19 mil. [is that we had] 54 PMAs last year and there were also 22 modular PMAs in house." Standard PMA fees for FY 2004 will increase almost 35% to $206,811 (1"The Gray Sheet" Aug. 4, 2003, p. 3)...

Regulatory News In Brief

Modular PMA policy tied to user fee shortfall: CDRH's decision to exempt modular PMAs from user fees if the first module was submitted prior to Oct. 1, 2002 resulted in higher PMA costs for fiscal 2004, Director David Feigal tells attendees during the Regulatory Affairs Professionals Society's annual meeting in Baltimore Oct. 19-22. "Had we made the opposite decision on modular 510(k)s, we would have hit the [FY 2003] fees right on the nose," he notes. "One of the reasons we didn't raise $25 mil. and only raised $19 mil. [is that we had] 54 PMAs last year and there were also 22 modular PMAs in house." Standard PMA fees for FY 2004 will increase almost 35% to $206,811 (1"The Gray Sheet" Aug. 4, 2003, p. 3)...

CDRH Continuous Process Improvement Initiatives Enter Phase Two

Implementation of a "TURBO 510(k)" template will be considered as part of a second round of continuous process improvement (CPI) initiatives at the Center for Devices & Radiological Health

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