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FDA Issues Reports on 510(k) Process

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The US Food and Drug Administration today issued two preliminary reports providing an assessment of the 510(k) program and evaluating the agency's use of science in decision-making.

The broad-based reviews offer recommendations for the agency in addressing three key objectives — fostering device innovation; creating a more predictable regulatory environment; and enhancing device safety. The reports were issued by the FDA's Center for Devices and Radiological Health, which regulates devices and diagnostics.

According to Jeffrey Shuren, director of CDRH, the reports reflect the input of people both within and outside of the center.

Among the recommendations put forth in the reports:

• CDRH should make major reforms in its implementation of the de novo process including steps to streamline the process and clarify the center's evidentiary expectations for de novo requests.

• CDRH should enhance training, professional development, and knowledge-sharing among its staff, to help ensure that appropriate scientific expertise and regulatory experience are used in decision making.

• CDRH should establish a network of external experts that would help inform the center about cutting-edge technologies — though such external experts would not serve in an advisory capacity.

• CDRH should develop a subset of class II devices, called class IIb devices, for which clinical or manufacturing information would typically be necessary to support a substantial equivalence determination.

• CDRH should clarify the meaning of key terms in the 510(k) "substantial equivalence" review standard to improve the consistency, transparency, and timeliness of the review process.

"Taken together, these preliminary reports show a smarter FDA — an agency that recognizes both sides of our mission to protect and promote public health," Shuren said in a statement. "The agency is ready to make necessary improvements to support device innovation while assuring patients receive safe and effective devices."

CDRH noted that the recommendations in the reports are preliminary, and that it is seeking comments on the recommendations, including the feasibility of implementation and potential alternatives.

The reports can be found on the CDRH website.

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