Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
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...