FDA issued a revised guidance on its medical device reporting requirements for manufacturers, including a new “frequently asked questions” section and a list of common errors made by device companies in their adverse event reports to FDA.
Draft Guidance Tackles Common Errors In Adverse Event Reporting
A revised guidance on medical device reporting fleshes out FDA’s thinking on manufacturers’ responsibilities in various situations.
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Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.