Developing mobile apps as medical devices: Understanding U.S. government regulations

What medical mobile app developers need to know

From the developerWorks archives

Erin Gilmer

Date archived: February 13, 2018 | First published: April 16, 2013

As mobile health and wellness applications proliferate in the marketplace, U.S. federal government agencies — most notably the Food and Drug Administration (FDA) — are preparing to impose regulations on those that they deem to be medical devices. In this article, get a detailed overview of the FDA guidance published to date, and learn how it impacts mobile app development. (Nothing in this article should be perceived as legal advice.)

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