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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.

US FDA has finalized a guidance in its push toward using patient-preference information (PPI) when reviewing medical device applications. In some cases where a product does not meet the agency's threshold for safety and efficacy, the agency could use input from patients, physicians and caretakers in the form of PPI to give a positive decision.

Over the years, FDA has been working with various stakeholders – including patient advocacy groups and industry – to get...

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