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Report: Health IT Products Not Subject to FDA Regulations

FDA logoThe Food and Drug Administration‘s new framework on medical device regulations deems health information technology products as different from medical devices and not subject to regulatory compliance, Federal Times reported Thursday.

Adam Stone writes the move was intended to help clear up the agency’s stance on medical technology and encourage further innovation from health IT developers.

“The FDA is a large government bureaucracy with a large regulatory framework for companies to jump through. There are all these steps that have to be accomplished and signed off on, and it just dramatically lengthens the time to approval,” said Christopher Longhurst, chief medical information officer at Stanford Children’s Health.

Divan Dave, chief executive officer of OmniMD, noted the framework focuses instead on the functionality of medical devices as the FDA emphasizes other quality assurance and risk controls such as industry testing and certification over regulation.

The FDA released the framework in April in partnership with the Federal Communications Commission and the Office of the National Coordinator for Health IT, the report said.

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