FDA overhauls 510(k) process

The FDA issued two evaluations containing recommendations that address three 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.

The FDA’s Center for Devices and Radiological Health (CDRH) 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.

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