10 issues that mobile medical app developers should keep in mind

1. Scope of FDA regulation - Two years since the release of the agency’s draft guidance, the FDA’s basic policy on mobile medical apps has stayed generally the same
2. Health and wellness vs. medical devices - One of the areas where clarity is needed relates to health and wellness apps targeted at specific patient populations
3. Accessories - Right now, if an app were an accessory to a class III product, then the app would also be class III, no matter how simple and low risk
4. Connections - Closely related to the issue of accessories is the question of where the regulated stream ends
5. Clinical decision support tools - One of the big FDA regulatory issues that has been developing parallel to the mobile apps guidance relates to regulation of clinical decision support tools
6. Non-mobile applications - Although the focus over the last few years has been largely on applications developed for mobile platforms, the FDA has historically regulated functionality, not platforms
7. Pathway for regulated apps - There are certain types of apps and standalone software products that have been regulated for years and for which the regulatory pathway is well understood
8. Quality system compliance - Much of the discussion regarding FDA regulation in this space relates to the need for companies to seek FDA clearance or approval prior to marketing
9. Changes to regulated products - It is important to understand that once a class II product is cleared by the FDA, a company must consider whether any change made to the product requires a new 510(k)
10. Enforcement - Since the draft mobile medical apps guidance was issued in 2011, there has been almost no public regulatory enforcement activity by the FDA

Source: mhimss.org
Source URL: http://www.mhimss.org/news/10-issues-mobile-medical-app-deve...

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