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Device Consortium Tries To Shed Light on Patient Risk-Benefit Preferences

This article was originally published in The Gray Sheet

Executive Summary

The public-private Medical Device Innovation Consortium issued a report outlining strategies for incorporating patient preference data into device applications.

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Final Guidance Encourages Use Of Patient Preference In Device Applications

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.

CDRH Prioritizes Leveraging Real-World And Patient-Preference Data, Enhancing Quality

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.

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Device manufacturers say labeling recommendations in FDA's recent draft guidance on applying patient-preference information for device submissions is burdensome and may lead to confusion among doctors and patients.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

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