Tag Archives: FDA

FDA

FDA Announces Funding Opportunities for Medical Device Development Tools

By MedTech Intelligence Staff
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FDA

The MDDT program was developed in collaboration with the National Institutes of Health’s (NIH’s) National Institute of Drug Abuse (NIDA), National Institute of Dental Craniofacial Research (NIDCR) and National Cancer Institute (NCI) as a way for the FDA to qualify tools that medical device sponsors can use in the development and evaluation of medical devices.

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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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