Statement from FDA Commissioner on how modern predicates can promote innovation and advance safety and effectiveness of medical devices that use 510(k) pathway

FDA

27 November 2018 - Earlier this week, the FDA announced new steps to modernise FDA’s 510(k) clearance pathway, used for low- to moderate-risk devices that are substantially equivalent to a device already on the market, known as a predicate device. 

These changes include a new pathway for these devices that we laid out in a draft guidance and discussed in our Medical Device Safety Action Plan that we issued in April.

The 510(k) pathway is used for the majority of devices that the FDA reviews. Manufacturers often rely on comparative testing to predicate devices to demonstrate that a new device is substantially equivalent to the predicate. A key part of our announcement is our intent to use our authorities to push for the use of more modern predicate devices. Today, I want to explain why predicate modernisation is a key component of promoting innovation to help patients access safe and effective treatments.

Read FDA statement

Michael Wonder

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Michael Wonder

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US , Regulation , Device