510(k) User Fee Rates May Make Third-Party Review More Attractive Option
This article was originally published in The Gray Sheet
Executive Summary
The addition of device user fees could boost participation in FDA's third-party review program for relatively simple 510(k) applications
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ODE/OIVD Fiscal 2003 Annual Report In Brief
Expedited PMAs review times: Average total review time for expedited PMA applications approved by the Office of Device Evaluation and the Office of In Vitro Diagnostic Device Evaluation & Safety in FY 2003 is 374.7 days, down from 471 days in FY 2002. However, the FY 2003 figure is still nearly 16 days greater than the average time for approved original PMAs. Elapsed FDA days averaged 304 for the six expedited submissions - 58 days longer than for the total PMA approval cohort mean. In November, FDA released a guidance on the expedited review program (1"The Gray Sheet" Dec. 1, 2003, p. 9)...
ODE/OIVD Fiscal 2003 Annual Report In Brief
Expedited PMAs review times: Average total review time for expedited PMA applications approved by the Office of Device Evaluation and the Office of In Vitro Diagnostic Device Evaluation & Safety in FY 2003 is 374.7 days, down from 471 days in FY 2002. However, the FY 2003 figure is still nearly 16 days greater than the average time for approved original PMAs. Elapsed FDA days averaged 304 for the six expedited submissions - 58 days longer than for the total PMA approval cohort mean. In November, FDA released a guidance on the expedited review program (1"The Gray Sheet" Dec. 1, 2003, p. 9)...
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Third-party review increases: FDA predicts roughly 170 510(k)s applications will be received under the third-party program in fiscal 2003, representing a 34% increase from the 127 premarket notifications in FY 2002 (1"The Gray Sheet" Dec. 16, 2002, p. 17). The rise continues an upward trend for the program. However, user fee implementation at the start of FY 2003 - requiring firms to pay for FDA review of 510(k)s - could have provided an additional spike in third-party submissions. Premarket notification submissions reviewed under the third-party program are not subject to FDA user fees, since manufacturers pay the third-party organization instead. FDA recently accredited two new third-party entities: Medtech Review, LLC in June and Regulatory Tech Services, LLC in July...