Article preview from "The Gray Sheet" - April 22, 2013
CDRH Director Jeffrey Shuren detailed last week how federal sequestration cuts to FDA are impacting specific device center programs, including training, standards development and regulatory science. Shuren also signaled imminent policy releases from the center, including a finalized post-market surveillance plan.
Article preview from "The Gray Sheet" - April 22, 2013
Training efforts, standards development and regulatory science programs within CDRH are being impacted by federal sequestration cuts that took effect March 1, according to Center Director Jeffrey Shuren.
FDA is facing an approximately 7.7 percent across-the-board cut this year under sequestration. While FDA, unlike many federal agencies, does not plan to furlough any employees as a result of the cuts, the reductions will be felt, Shuren made clear April 16 at the Medical Device Manufacturers Association annual meeting in Washington, D.C.
Shuren stressed that CDRH is still committed to meeting its medical device user fee agreement goals for fiscal year 2013.
“We still are focused on making good on MDUFA III. It creates challenges for us, but we are moving forward to meet the goals we have in place and keeping the people we need to have on board,” he told MDMA meeting attendees.
“But I’ll tell you, we are at that point where we’re continuing to see more cuts in the future; it certainly will make it more challenging to make good on all the promises we have in place, but we are not reneging on the commitments we’ve made,” he added.
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