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Medical Devices / Regulatory Affairs

CDRH Leading the Way on Agency-Wide Policy

Oct. 3, 2017
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Policy advances at CDRH are “going viral” across the entire agency, FDA Commissioner Scott Gottlieb said in his keynote speech on Sept. 26 at the 2017 AdvaMed Medtech conference.

CDRH has been busy this year implementing components of the FDA’s new Digital Health Innovation Action Plan aimed at encouraging innovation and speeding up the pre-market process for quality medical technologies.

The FDA plans to use some of the new policies and regulatory concepts that the center has put into practice as models for agency-wide adoption as the medical device area has been able to advance innovation at a faster pace for several reasons.

One of the more obvious reasons, Gottlieb noted, is that the innovation process for devices is “more iterative” as they “are constantly being adapted and improved based on feedback from the end users and from their performance in clinical practice.”

One lesson learned from CDRH is its approach to reviews, product and manufacturing quality as well as post-market surveillance. CDRH launched a pilot called Total Product Life Cycle Office to shift to this approach, which Gottlieb described as “more holistic” as products are evaluated throughout the entirety of their lifecycle.

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