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Firms Bristle At Labeling Requirements For Patient-Preference Data

Device manufacturers say labeling recommendations in FDA's recent draft guidance on applying patient-preference information for device submissions is burdensome and may lead to confusion among doctors and patients.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.

Labeling recommendations in FDA's recent draft guidance

on how to incorporate patient preference data in device applications will be too burdensome for device manufacturers, and could confuse physicians and their patients, industry groups say.

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