Tag Archives: Final Guidance

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FDA Releases Final Guidance on Premarket Submissions for Device Software Functions

By MedTech Intelligence Staff
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“Content of Premarket Submissions for Device Software Functions” covers recommended documentation sponsors should include in premarket submissions for FDA’s evaluation of safety and effectiveness of device software functions. The agency is hosting a webinar for industry on July 20 to provide an overview and answer questions about the new final guidance.

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FDA Issues Final Guidance on Technical Performance Assessments of Quantitative Imaging in Premarket Submissions

By MedTech Intelligence Staff
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Manufacturers preparing premarket submissions should provide performance specifications for the quantitative imaging functions, supporting performance data, and sufficient information for the end user to obtain, understand and interpret the values provided.

Manufacturers preparing premarket submissions should provide performance specifications for the quantitative imaging functions, supporting performance data, and sufficient information for the end user to obtain, understand and interpret the values provided.

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