FDA Final Mobile Medical Apps Guidance

FDA released a final guidance entitled ” Mobile Medical Applications” dated 25-Sep-2013. This guidance explains FDA’s current policies regarding regulation of Mobile Medical Applications. It provides criteria and examples of Mobile Medical Apps that are considered Medical Devices; for these it explains which are subject to FDA regulation and which will not require compliance with the medical device regulations. It also explains criteria for which Mobile Applications, platforms, and services (e.g., distribution) are not considered regulated Medical Devices. This guidance is quite specific and definitive in many respects and for certain intended uses (e.g., medicine reminder systems, personal health coaching and others). The full guidance is at the link provided.

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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