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Third-Party Review: FDA Seeks Tangible 510(k) Results Over Next Three Years

Under a new plan and draft guidance issued by US FDA, the agency is hoping to streamline and improve its third-party review program. The goal is to spend substantially less FDA resources re-reviewing low-to-moderate risk 510(k) applications that go through the program and allow products to enter market sooner.

If things go according to plan, US FDA says in three years almost all low- and moderate-risk 510(k) devices reviewed by a certified third-party entity will not require substantial re-reviewing by its own staff. The regulators say this will significantly ease up on its resources so the agency can focus on higher-risk and more complicated products, while allowing third-party reviewed products to get to market faster.

On Sept. 13, FDA released an ambitious plan and an accompanying

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