FDA Sanofi Aventis recall of Mobile App

This is one of the first mobile medical app recallsl we have seen posted. It is for an app that was only intended to be released in Brazil but was published on the iPhone store and available in the U.S. Its intended use is diabetes education. The full recall excerpt is available on our Recalls page dates Jan 2, 2013.

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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