FDA Announces Public Workshop for Medical Apps
On August 12, 2011, the U.S. Food and Drug Administration (FDA) announced its plans to hold a public workshop concerning its newly proposed regulation of mobile medical applications (“apps”). The meeting, which is scheduled for September 12, will focus on the emerging phenomenon of medical apps, defined as those applications used to diagnose or treat conditions.
As we previously reported, the FDA has recently been focusing in on medical apps inasmuch as they are transforming mobile devices into medical devices that are regulated by the Agency. Having issued its draft guidance last month, found here, the FDA is holding this workshop in an effort to gain further feedback from the public. The FDAs proposed oversight of these apps will be through the application of the same regulatory scheme that applies to traditional medical devices, and the workshop will provide the public with a forum to present the FDA with its concerns before the Agency finalizes its position on this new area of medical device regulation.
Fuerst Ittleman will continue to monitor the progress of the FDAs regulation of mobile medical apps. For more information, please contact us at contact@fidjlaw.com.