RCRI: How to work with the new FDA
Medical device makers have the opportunity to capitalize on the strategic priorities and transparency initiatives at FDA’s CDRH, according to Lisa Olson, president of medical device strategic consulting company RCRI.
“When the totality of FDA actions and external communications are evaluated, the agency is still demonstrating a focus on the strategic priorities set out in 2016,” Olson said in a recent article she wrote for MDO.
“The initial priorities set forth in 2016 focused on three main topics: establishing a national evaluation system, partnering with patients and promoting a culture of quality and organizational excellence,” Olson said. Read on to find out more.
(Network with RCRI experts at DeviceTalks West, Dec. 11–12 in Orange County, Calif.)
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