FDA Revised Mobile Medical App Guidance Feb 2015

FDA issued a revision to its “Mobile Medical Applications” Guidance Feb 9, 2015. The revision was to make this guidance consistent with the final “Medical Image Storage Devices, and Medical Image Communications Devices” guidance. Specific changes are FDA’s exercising of enforcement discretion to exempt MDDS and some Mobile Medical Apps from compliance the FDA regualtion. Section V.B identifies types of MMapps for which FDA would not enforce requirements. Appendix A gives exampels of MMApps that are not considered medical devices and Appendix B gives example of MMApps that may be medical device but for whch FDA is exercising its enforcement discretion and not enforcing compliance.

https://www.fda.gov/downloads/medicaldevices/…/ucm263366.pdf

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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