HHS Committee Says FDA's RWE Device Guide Too Vague To Be Useful

HHS' human research protections committee is considering pushing FDA to provide more clarity on its policies related to use of real-world data (RWD) to support medical device decisions, including when use of such data will be considered an FDA-regulated clinical investigation, according to a draft of recommended changes to FDA's guidance on use of real-world evidence (RWE) in regulatory decision-making, which was obtained by Inside Health Policy. The committee says FDA's guidance as it stands is too vague to be...