Filtering by Tag: 510(k)

FDA sets novel device approval record for 2018, outlines new criteria for 510(k) clearances

In 2018, the FDA achieved a new record of approving 106 new devices.

The FDA also outlined the latest steps in its plan to strengthen the 510(k) clearance program, including a new final guidance for moderate-risk devices to use a separate set of criteria in their demonstrations of substantial equivalence to already-marketed devices.

Categories: regulatory
Tags: FDA, 510(k)

Published on by Winnie So. Source.

FDA finalizes breakthrough device guidance, plugs new safety innovation pathway

The FDA has finalized its new device guidance program: the Safer Technologies Program (STeP). It assess products that may not meet the high criteria for the Breakthrough Devices Program, but that would still offer significant benefits in safety compared to current devices or diagnostics. Other documents expected in 2019 include the final guidance on the 510(k) program.

Categories: regulatory
Tags: FDA, STeP, 510(k)

Published on by Winnie So. Source.

International investigation links 1.7M injuries to medical devices, as FDA moves to reform its 510(k) process

The FDA plans to update the guidelines of its 510(k) clearance program, which allows manufacturers to compare their products against previously cleared predicate devices to demonstrate that they are just as safe and effective. More clarity from the FDA is expected in the coming weeks and the finalized guidelines are expected to be released in early 2019.

Categories: regulatory
Tags: FDA, 510(k)

Published on by Winnie So. Source.

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

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 In draft guidance (PDF), the FDA set out how sponsors can win clearance for devices after showing they meet certain performance levels, rather than through direct comparisons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.

“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,” FDA commissioner Scott 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. 

Categories: diagnostics, regulatory

Published on by Winnie So. Source.