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Originally Published MD&DI November 2007

NEWS TRENDS

MDUFMA II Becomes Law

President Bush on September 27 signed the FDA Amendments Act of 2007, which includes the new version of the Medical Device User Fee and Modernization Act. The law, among other things, extends the user-fee program for another five years, provides incentives for device makers to conduct pediatric studies, and directs CDRH to come up with a unique device identification scheme.

This means there will be no disruption of FDA’s work. Had the law not been signed before October 1, all FDA staff whose salaries come from the user-fee budget would have had to be laid off.

More information about the act can be found in the editors’ letter in the October issue of MD&DI.














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