Guidance: What The Patient Prefers, And How To Make It Part Of Your FDA Submission
This article was originally published in The Gray Sheet
FDA draft guidance lays out how to collect patient preference data and how to present the preferences on device labels. The guidance supports a growing emphasis by FDA to formally incorporate patient input into regulatory decision-making.
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In its 2016-2017 strategic priorities, the device center lays out specific goals for putting more emphasis on real-world postmarket data to support regulatory decisions, making better use of patient-preference input, and enhancing quality at CDRH and in industry. Topping FDA's list: gaining access to 25 million electronic patient records with device identification from global registries, insurance claims data and electronic health records, and expanding that number to 100 million by the end of 2017 to support premarket and postmarket decisions.
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.
Device manufacturers say labeling recommendations in FDA's recent draft guidance on applying patient-preference information for device submissions is burdensome and may lead to confusion among doctors and patients. Meanwhile, Public Citizen says FDA should abandon the guidance because it lowers approval standards.