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imaging
On February 25-26, 2020 the U.S. Food and Drug Administration (FDA) held a public workshop to discuss the “Evolving Role of Artificial Intelligence in Radiological Imaging.” The comment period for the public workshop is extended to June 30, 2020, in response to requests for an extension to allow stakeholders additional time to submit comments.
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In April 2019, FDA released a draft guidance providing manufacturers and FDA staff with detailed recommendations on assessing the technical performance of quantitative imaging devices and how the documentation from those assessments should be provided in premarket submissions. From a big picture perspective, one should remember the overall goal is to “provide performance specifications for...
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What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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