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FDA to Rely More on 510(k) Reviews Conducted by Third Parties

September 25, 2018

The FDA released a comprehensive new plan that proposes to rely more on reviews conducted by third parties to streamline its review process and avoid re-reviews of 510(k) applications.

The plan is aimed at improving efficiency and consistency of the premarket notification process, with a goal to have 85 percent of third-party submissions not re-reviewed by the agency by 2021.

FDA Commissioner Scott Gottlieb said the third-party reviews “must be equivalent in rigor and completeness to the kinds of reviews that we’d conduct.”

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