FDA Issues Assessments of the 510(k) Program and Use of Science in Decision-Making

FDA Issues Assessments of the 510(k) Program and Use of Science in Decision-Making

Recommendations focus on innovation, regulatory predictability, and patient safety

 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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