CDRH In 2012: More Pilots, Guidances And Regs
By
Rebecca Kern / Email the Author / “The Gray Sheet” Jan. 30, 2012, Vol. 38, No. 05
Regulatory / Word Count: 1533 / Article # 01120130010
Executive Summary
The device center plans to finalize all the 510(k) program guidances it issued last year, among a boatload of 2012 priorities. Many of this year's top goals spring from the 510(k) and “science in regulatory decision making” reform programs that commanded attention in 2011.
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