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Posted 05 December 2012 | By Alexander Gaffney, RAC,
It's that time of year-the holidays, yes, but also when companies and agencies are putting the final touches on their planning documents for 2013. The US Food and Drug Administration (FDA) is no exception to this trend, and its Center for Devices and Radiological Health (CDRH) has just published its 2013 Strategic Priorities plan.
Calling the plan a continuation and expansion of its efforts to promote "smart regulation," CDRH said it is reorganizing its plan to better meet its vision of providing US consumers access to "high-quality, safe and effect medical devices of public health importance."
"The primary purpose of CDRH's 2013 Strategic Priorities is to inform the public of some of the most important actions we are committing to implement this year to better understand the direction the Center is heading in and what to expect from us this year," Jeffery Shuren, director of CDRH, wrote. "It is not intended as a comprehensive blueprint of every action the Center may take in the coming months."
2013 may well shape up to be a transformative year for the medical device center. Thanks to the FDA Safety and Innovation Act (FDASIA), a massive piece of legislation passed in July 2012, the center is flush with resources and is in the midst of some big regulatory actions, including the early stages of implementing its Unique Device Identification (UDI) rule.
"We consider implementation of FDASIA to be a top priority for CDRH," Shuren wrote. "However, because the FDA has provided a separate mechanism to inform the public of its efforts to implement FDASIA, we have generally not included actions specifically directed at implementing FDASIA in our 2013 Strategic Priorities."
What the strategic plan does contain is a number of timelines by which the center wants to have certain tasks accomplished, including a huge number of guidance documents and reports likely to be of use to industry.
The following list quotes extensively from FDA's Strategic Priorities plan, and includes all relevant dates by which the center hopes to accomplish certain tasks, as sorted by content areas.
Tags: Strategic Plan, 2013, Shuren, Latest News, plan, staff, guidance, medical device
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