The FDA’s medical device arm released its strategic priorities for the year, saying it plans to focus on 4 areas.
The watchdog agency’s Center for Devices & Radiological Health said it plans to concentrate on fully implementing a "total product life cycle approach," enhance its internal and external communication and transparency, strengthen its workforce, and "proactively facilitate innovation."
The priorities include a pilot program to triage pre-market applications "to increase submission review efficiency and better manage the pre-market review workload," according to the agency. The program is slated to begin April 1. The FDA also wants to publish a proposal "to clarify the circumstances under which CDRH could rely on clinical studies conducted in and for other countries by Dec. 31. And it hopes to finalize all the guidance documents related to its plan to improve the pre-market programs by the end of the year.
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"In 2012, CDRH will continue to take steps to address Class III device types currently allowed to enter the market through the 510(k) process," according to the FDA, which pledged to "clear within CDRH proposed rules for all remaining Class III pre-amendment medical devices."
And by the end of October the agency "will take steps to enhance the efficiency and clarity of the medical device and radiation-emitting product recall processes," including the development and implementation of criteria for terminating recalls "including online posting of recall terminations."
The FDA is also planning to work on its post-market surveillance program, saying it will "develop a comprehensive strategy to assess real-world device performance" by Oct. 31.
Seeking to address criticism that it stifles medical device innovation, the agency said it will "will create processes and tools that will improve the pipeline for innovative medical devices and transform the way CDRH works with medical device innovators" by Sept. 30 and begin to pilot "Innovation Pathway 2.0" by March 31, using its Entrepreneurs in Residence Program.
