103 FDA Regulated Mobile Medical Apps


103 FDA Regulated Mobile Medical Apps

103 FDA Regulated Mobile Medical Apps 2013

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How many mobile medical apps have been cleared by the FDA? That is the question that served as the premise for MobiHealthNews' ground-breaking report at the end of 2012, which has now been updated with more than two dozen newly cleared and discovered regulated medical apps. As of the end of 2013, MobiHealthNews has found more than 103 mobile medical apps in FDA's databases for Class I, Class II, and Class III devices. (Yes, contrary to FDA's own testimony to Congress, there is at least one Class III mobile medical app!)

What kinds of apps have received FDA clearance to date? Is FDA clearance for mobile medical apps increasing in frequency? Which apps were among the earliest to secure 510(k) status? How many of these apps are patient-facing vs. provider only? How many apps were cleared for OTC rather than being prescription-only?

MobiHealthNews’ analysis of 103 FDA Regulated Mobile Medical Apps answers these questions and more. In its more than 35 pages the report also includes a recap of important FDA maneuvers related to mobile app regulation over the course of the last five years. It also includes a substantial appendix with listings for all 103 of the FDA regulated medical apps — along with links to their FDA summary documents or registrations.

If you are considering FDA clearance for your mobile medical apps, this report is a must-read.

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Page count: 48

Table of Contents:

I. Metrics: The FDA Cleared Mobile Medical Apps (MMAs)
II. Recapping FDA’s Five Year Focus on MMAs

Appendix I: MMA FDA Registrations (Class I)
Appendix II: MMA 510(k) Clearances (Class II)
Appendix III: MMA 510(k) Clearances (Class III)


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