Industry Meets With FDA On Mobile Health Regulatory Plan

Article preview from "The Gray Sheet" - January 12, 2011

Members of the mHealth Regulatory Coalition representing the medical device, wireless communication and software industries met Jan. 10 with more than a dozen FDA staffers to discuss next steps for creating agency guidance on mobile health devices.

Industry Meets With FDA On Mobile Health Regulatory Plan

Article preview from "The Gray Sheet" - January 12, 2011

Meeting attendees included CDRH Director Jeff Shuren and Policy Advisor Bakul Patel.

The mHealth Regulatory Coalition was created last year to help draft proposed guidance for FDA consideration. (See "¹ Industry Coalition To Draft mHealth Guidance For FDA's Consideration" - "The Gray Sheet" Sept. 13, 2010.)

Lack of clarity over when and how mobile health technology (such as health care-related smart phone applications) would face regulatory exposure continues to inhibit some investors in the field.

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