Article preview from "The Gray Sheet"- January 30, 2012
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.
Article preview from "The Gray Sheet"- January 30, 2012
After a busy year developing 510(k)-related draft guidance documents, FDA's device center will focus in 2012 on finalizing the new policies and initiating other programs to improve pre-market review efficiency.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 director for external affairs, said in an interview.
The device center issued its 2012 strategic priority list
last week. The list specifies 35 goals, including many that spring from the 510(k) and “science in regulatory decision making” reform programs that commanded attention in 2011.
Many of the priority goals are not expected to be reached until late in the year, but two pilots slated to begin soon could lead to big changes in how reviewers approach new devices, officials say.
By the end of March, the device center says it will officially start its “Innovation Pathway 2.0” pilot. CDRH announced plans for the first iteration of the accelerated development and review process last year, with a focus on a Defense Department-developed prosthetic device. The center is working with outside entrepreneurs and others to further develop and expand the program, which aims to facilitate the pre-market path of innovative new devices from the earliest stages. The second iteration will be applied to additional devices, relying on novel statistical tools and robust early interaction between regulators and sponsors.
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