Congress to Discuss FDA Regulation of mHealth Apps

3-12-2013 11-21-01 PM

Next week, members of the House Energy and Commerce committee will discuss how the FDA should approach regulation of medical apps. The meetings, which will span three days, will specifically look at how regulation affects patients, physicians, and developers.

FDA clearance of products can take years and cost companies millions. Overcoming these process barriers will be critical to mHealth app developers, who often work on small profit margins.

The FDA already has somewhat of a knowledge base in the area of approving mHealth apps. Since 2012 it has been approving apps that work in conjunction with or as an accessory to existing medical devices. Those approvals have come at a much more reasonable 130-145 day timeframe.

In June of last year, the FDA was charged with the task of publishing a broad strategic plan for which apps would require FDA approval, and how the process would work, and while the FDA has started reviewing medical device connected apps, the agency has not issued any final guidance on its regulatory authority in the marketplace. The details of this emerging plan will be the primary point of discussion during the meetings.

Also on the table for discussion will be if the smartphones themselves would be considered a medical device once medical apps become regulated. If so, there could be tax implications that lawmakers worry will dampen innovation and stall market growth.

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