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FDA To Consider Patient Input For Benefit-Risk Decisions For IDEs

The agency will take into account patient preferences when making benefit-risk determinations for investigational device exemptions, according to a June 18 draft guidance.

FDA says it is willing to consider sponsor summaries of available patient preference information, as well as companies’ assessments of benefits and risks when making benefit-risk determinations on investigational device exemption applications in a June 18 draft guidance

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