Substantial Equivalence Factors Explored In FDA Draft Guidance on 510(k) Reviews

The FDA has released a document to increase awareness of the factors it considers when making premarket notification submission decisions for new devices.

The July 15 Food and Drug Administration draft guidance said that the agency issued the document “to improve the predictability, consistency, and transparency of the” device premarket notification process, also known as 510(k). Comments on the draft guidance are due Oct. 14, according to a July 15 Federal Register notice announcing the document (Docket No. FDA-2014-D-0900).

Specifically, the draft guidance offers information on the factors considered in a 510(k) when determining substantial equivalence (SE) to a legally ...