[IEEE-bhpjobs] first message

[Esther L.]

I attended the PEERS (part 11) meeting this morning, and the NCRAF meeting
this evening.  Both were good.

At PEERS, the Director of Software Integration at eTrials.com gave a short
presentation about their electronic patient diary software for clinical 
trials.

At NCRAF, a lawyer gave a presentation about MDUFMA, the Medical
Device User Fee Modernization Act.  In this law, industry, the FDA, and
Congress made a deal about funding the FDA.  FDA can charge user fees
to manufacturers who submit applications for the market approval of new
devices.  Congress agreed to give the FDA $14M for FY 2003 for Devices.
The law also allows the FDA to increase device fees every year, depending
on the number of applications received in prior years, and the 
forecasted funding.
However, Congress gave the FDA $11M less than promised for FY 2003.
Small device companies are rather upset that the FDA is raising device fees
for next year, in part to cover the funding shortfall.

There was a lot more information in the NCRAF presentation.

thanks,
Esther Lumsdon, RAC

-- 
-- Esther L. esther_l at ieee.org, 
Speaking only for myself