Firms Bristle At Labeling Requirements For Patient-Preference Data
This article was originally published in The Gray Sheet
Device manufacturers say labeling recommendations in FDA's recent draft guidance on applying patient-preference information for device submissions is burdensome and may lead to confusion among doctors and patients.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.
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US FDA released a final guidance aimed at helping sponsors and other stakeholders interested in using patient-preference information to make their case for a device application. The agency has decided to keep its labeling recommendation in the final guidance despite industry objections.
FDA draft guidance lays out how to collect patient preference data and how to present the preferences on device labels.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.
The public-private Medical Device Innovation Consortium issued a report outlining strategies for incorporating patient preference data into device applications.