Clarity for US medtech industry on when FDA can 'disapprove' trial applications
This article was originally published in SRA
Executive Summary
The US Food and Drug Administration has issued final guidance to support the timely initiation of medical device trials and to clarify, among other things, the situations in which the FDA cannot disapprove a trial application1,2. When finalizing the guidance, the FDA decided not to go ahead with a proposal for a new voluntary process that would have helped companies determine whether a trial design would lead to market approval of their product.