How the FDA will revamp its 510(k) medical device clearance pathway: 7 major points

Written by Shayna Korol | November 28, 2018 | Print  |

The FDA will overhaul its 510(k) clearance pathway for medical devices.

Here are seven things to know:

1. The 510(k) program is the most commonly used device premarket review pathway. In 2017, the FDA's Center for Devices and Radiological Health cleared 3,173 devices through the 510(k) pathway, representing 82 percent of the total cleared or approved devices.

2. Through the 42-year-old pathway, manufacturers generally rely on comparative testing against predicate devices to show a new device is as safe and effective as the model it is based on. Nearly 20 percent of current 510(k)s are cleared based on a predicate more than 10 years old.

3. The public comment period on the FDA's Medical Device Safety Action Plan, which it issued in April, closed Nov. 26. The FDA now intends to update the pathway to keep up with, "advances in material science, digital health, 3D printing and other technologies."

4. CDRH is considering making the cleared devices that demonstrated substantial similarities to older predicate devices publicly available on its website. The FDA begin by focusing on predicates more than 10 years old to drive sponsors to offer devices with the latest advances.

5. The FDA is developing proposals to potentially sunset certain older predicates and promote the use of more recent predicates. This approach may become a future requirement, and the FDA may seek additional guidance from Congress.

6. In early 2019, the FDA aims to finalize guidance to establish an alternative 510(k) pathway, which will be renamed the Safety and Performance Based Pathway, in which companies must demonstrate a novel device meets modern performance-based criteria.

7. As a result of the 510(k) policy proposals, the FDA believes more devices will go through the de novo pathway.

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