75 FDA Regulated Mobile Medical Apps
How many mobile medical apps have been cleared by the FDA? That is the question that served as the premise for this ground-breaking report. MobiHealthNews found more than 75 mobile apps mentioned in the summary descriptions that the FDA provides in its 510(k) database.
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 75 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 four years. It also includes a substantial appendix with listings for all 76 of the FDA-cleared medical apps — along with links to their FDA summary documents.
If you are considering FDA clearance for your mobile medical apps, this report is a must-read. CLICK HERE TO PURCHASE!
Page count: 38
Table of Contents:
I. Metrics: The FDA Cleared Mobile Medical Apps (MMAs)
II. Recapping FDA’s Four Year Focus on MMAs
II. Appendix: 75+ MMAs in 510(k) Clearance Chronological Order