FDA CDRH FDLI Medical Device Update Presentation

Linda S. Kahn of FDA is CDRH gave a presentation for the Food and Drug Law Institute in June of 1999 entitled “Medical device update “. Several of her slides addressed software and Computerized Devices. One of these slides listed the number of software related submissions by type of product including a category for artificial intelligence and visual recognition programs. The title slide and the software related slides are provided here.

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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