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CDRH Staff Credits Advocacy Groups For Patient Preference Guidance

Top CDRH officials say while they have been working to incorporate patient preference into their regulatory process, it was the push from patients to get more involved in the agency's decision making process that led the agency to develop a new draft guidance on the topic.

FDA officials say the persistence of patient groups and CDRH director Jeffrey Shuren's support pushed the agency to incorporate patient views into their review process.

Kathryn O'Callaghan, acting associate director for Science and Strategic Partnerships at CDRH, says the agency has been working to consider patient views as part of device reviews such as by...

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