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FDA Launches Patient Engagement Advisory Committee For Devices

This article was originally published in The Gray Sheet

Executive Summary

FDA is seeking nominations for a new Patient Engagement Advisory Committee to help the agency’s device center understand patients’ experiences with medical technology and FDA communications and allow them more input to inform regulatory decisions.

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FDA Will Keep Listening To Patient-Engagement Experts

The US agency says in a 6 January Federal Register notice that it’s keeping its Patient Engagement Advisory Committee in place through October 2021 so it can gather more patient feedback that will come in handy when regulatory decisions need to be made. The committee, formed after the agency made a cultural shift to consider patient input on the types of products it allows on the market, was supposed to expire October 2019.

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Some device user fee revenue could be used to enhance application of patient-preference data, FDA said at a recent meeting of patient and consumer groups about user-fee reauthorization. Several groups urged greater emphasis in that area at the closed-door meeting, and some groups also pushed for increasing device user fees closer to the much higher levels charged to drug firms.

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