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More Resources Sought For Using Patient-Preference Data In Device Reviews

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.

FDA’s vision for the next Medical Device User Fee Act is to ensure the reliability and sustainability of the device review program, but it is also considering "other components" not traditionally considered, such as how to get resources to include patient preferences in decisionmaking, the agency said in minutes

of a recent MDUFA IV patient/consumer stakeholder meeting.

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