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Medical Devices / Regulatory Affairs

FDA Unveils Abbreviated 510(k) Review Pathway

Jan. 30, 2019

The FDA released final guidance on its abbreviated 510(k) review process, which it has renamed the Safety and Performance Based Pathway.

Last April, the FDA issued draft guidance proposing an expanded abbreviated 510(k) clearance program that would allow companies to show a new product’s substantial equivalence to an existing device using performance criteria rather than directly comparing the device’s performance to a predicate device.

Almost 20 percent of current 510(k) clearances are based on predicates that are more than a decade old, and the agency wants to promote the use of more modern predicates to compare devices to newer technology.

Under the program, if a predicate device meets performance criteria for safety and effectiveness and a new device meets or exceeds the same levels, the agency could deem the device as safe and effective as the predicate.

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