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FDA guidance steers clear of regulating medical device data systems

Healthcare providers can breathe a sigh of relief after the FDA passed up a chance to throw another health IT requirement their way.

The FDA issued draft guidance saying they will not enforce any regulations that apply to medical device data systems (MDDS), medical image storage devices, and medical image communications devices because of “the low risk they pose to patients and the importance they play in advancing digital health.” The FDA guidance details the history of their involvement with MDDS, noting that in 2011 the devices were downgraded from class III (high-risk) to class I (low-risk).

This of course is a proposed guidance document circulated for the purposes of collecting comments on what will likely become changes in regulatory law down the road in formal rulemaking updates.

The CMS’ latest release also proposes updates to their “Mobile Medical Applications” guidance issued in September 2013. That plan disclosed how the FDA plans to monitor the use mobile applications in a healthcare context. The FDA will assess the functionality of an application and determine how strictly they should regulate its use — if at all. The agency expects that most apps will not be subject to regulation. They will be “reviewing only the mobile apps that have the potential to harm consumers if they do not function properly,” Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, said in an FDA release.

The FDA’s plan for regulating mobile applications was called into question earlier this year, in the form of a letter signed by six U.S. Senators. The letter asked the FDA to be more forthcoming with their plans to regulate medical software and to avoid stunting development by overregulating — two conditions that appear to have been met in the agency’s recent medical device data systems guidance.

Many medical devices are categorized as class I devices by the FDA. This classification makes device manufacturers exempt from filing a 510(k), which otherwise would require them to submit notice to the FDA 90 days prior to marketing their application or product. Most devices labeled as class II by the FDA need to be accompanied by a 510(k) and clinical information proving the accuracy and reliability of the device or application.

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