User Fee Funds Will Not Be Confined To Premarket Review Activities – Feigal
This article was originally published in The Gray Sheet
Executive Summary
Device user fees will be allocated toward activities other than premarket review as CDRH struggles to compensate for fiscal 2003 appropriation shortfalls
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MassMEDIC lobbies for CDRH funding
A March 20 letter to Massachusetts' congressional delegation from the device trade group urges members to work with House Appropriations/Agriculture Subcommittee Ranking Democrat Marcy Kaptur (Ohio) to ensure CDRH receives the additional $22 mil. (plus inflation) in FY 2004 approps needed to keep MDUFMA implementation on track. "This approach ensures that user-fee funds do not displace congressional appropriations, and allows CDRH to upgrade information technology and other infrastructure necessary to carry out a user-fee program and meet the performance goals," MassMEDIC President Tom Sommer writes. CDRH Director David Feigal has indicated the center may use industry fees to compensate for budget shortfalls (1"The Gray Sheet" March 17, 2003, p. 3). The device center must receive $45 mil. (plus inflation) by FY 2005 or the program sunsets...