FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

MDIC Requests Comments on Best Practices for Explaining Benefits, Risks

Aug. 20, 2019
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The Medical Devices Innovation Consortium is looking for feedback on its white paper on best practices for communicating medical device benefits, risks and uncertainties to providers and patients.

Designed as a resource for device regulators, scientists conducting trials, clinicians and others, the paper is part of the consortium’s framework for patient input in device clinical trials.

“During approval and subsequent use of a device, manufacturers and regulators have an obligation to ensure that device benefits, risks and uncertainty are communicated in an understandable way,” the consortium said.

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