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FDA Issues Assessments of the 510(k) Program and Use of Science in Decision-Making
Date:8/4/2010

Recommendations focus on innovation, regulatory predictability, and patient safety

SILVER SPRING, Md., Aug. 4 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today issued two comprehensive evaluations containing recommendations that address three key objectives of the agency's public health mission as it relates to medical devices – foster device innovation, create a more predictable regulatory environment, and enhance device safety.

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The FDA's Center for Devices and Radiological Health assessment consists of two preliminary reports. One report focuses on ways to strengthen and clarify a premarket review process called the 510(k) program for medical devices that do not need to undergo a full premarket approval review. The other evaluates CDRH's use of science in decision-making, with an eye toward adapting to new scientific information, while maintaining regulatory predictability necessary for innovation.

The two documents overlap in several places and cross-reference information. The documents can be found online at

SOURCE U.S. Food and Drug Administration
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