FDA CDRH CADx Workshop Summary

On June 26, 1996 FDA held an open public workshop a on computer-aided diagnosis and medical devices as a step in developing further policy and guidances for such devices/software. Summaries of the presentations and participant comments are provided in this text.

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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