FDA’s 510(k) overhaul floats end to predicate testing for some devices

The FDA acknowledges that direct comparisons to predicate devices can place avoidable burdens on sponsors. (FDA)

The FDA is planning to expand its abbreviated 510(k) program to lessen the burden of demonstrating substantial equivalence. In draft guidance (PDF), the FDA set out how sponsors can win clearance for devices after showing they meet certain performance levels, rather than through direct comparisons with predicate products.

The FDA introduced an abbreviated 510(k) pathway 20 years ago. The pathway allows developers of certain devices to use evidence showing a product conforms with FDA guidance to win clearance. Officials saw the pathway as a way to leverage the growing body of medical device guidance documents and other regulatory materials to streamline the clearance process. But the approach is only applicable to some performance characteristics, meaning sponsors still need to compare their devices to predicates. 

FDA commissioner Scott Gottlieb, M.D., thinks that creates problems for device developers and the agency.


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“Predicates can be old, and in certain cases, they might not closely reflect the modern technology embedded in new devices,” Gottlieb said in a statement

In the draft guidance, the FDA acknowledges that direct comparisons to predicate devices can place avoidable burdens on sponsors. The agency cites the need to test a device against a “substantial number” of predicates as an example of when the approach is unnecessarily burdensome.  Driven by a 21st Century Cures Act that tasks it with applying “least burdensome” principles, the FDA is planning to reduce reliance on testing against predicates.

The FDA’s big idea is to allow firms to use the conformity mechanisms established in the abbreviated 510(k) pathway to demonstrate all the performance characteristics, not just a subset. Only some devices will be able to take this approach, but the FDA thinks the pathway will make a difference despite these restrictions.

“By allowing a set of objective, transparent and well-validated performance metrics to serve as the benchmark for evaluating some new devices, this new pathway offers a more efficient and less burdensome option,” Gottlieb said.

In freeing sponsors from predicate testing, the FDA also thinks it can streamline the review process for its own staff, lessening the burden the task places on it and potentially shortening clearance times. 

The draft is open for comment for the next 90 days. 

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