FDA mHealth Proposal ‘Big News’

The FDA’s latest mHealth draft guidance reduces approval requirements for certain mobile devices. The agency proposes to largely deregulate a sizable list of Class II and Class I medical devices and no longer require their makers go through the 510(k) process. “This is big news, and a huge boost to the mobile health industry,” the mHealth Regulatory Coalition’s Bradley Merrill Thompson wrote MobiHealthNews in an email. Read the source article at healthitoutcomes.com

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