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Comments OffJanuary 27, 2014by in

Attorneys, FDA and industry groups have teamed up to tour the country and educate innovators on how to navigate mobile medical app regulations.

The Gray Sheet, January 27, 2014

“The idea is to give innovators support by sharing experience,” Bradley Thompson, a lawyer at Epstein Becker & Green and the head of the mHealth Regulatory Coalition, wrote “The Gray Sheet” in an e-mail.

To that end, Thompson organized the tour, focusing on universities as “hubs of innovation.” Each stop will feature several speakers and groups: Bakul Patel, senior policy advisor at CDRH who spearheads the center’s mobile health policy development; a lawyer from Epstein Becker & Green; Erik Vollebregt, a lawyer from Axon Lawyers in Amsterdam, discussing the impact of European Union regulations in mobile health; and local developers who have already taken apps through FDA’s clearance and pre-market process.

For the full article: http://www.elsevierbi.com/publications/the-gray-sheet/40/4/attorneys-fda-hit-the-road-to-instruct-on-mobile-health-regs



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