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CDRH In 2012: More Pilots, Guidances And Regs

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.

After a busy year developing 510(k)-related draft guidance documents, FDA's device center will focus in 2012 on finalizing the new policies and initiating other programs to improve pre-market review efficiency.

“This year is very similar to 2011 in that we’re continuing the momentum on the work that we’ve already started,” Peper Long, CDRH’s associate

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