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FDA won’t regulate medical device data systems, image storage

By Jennifer Bresnick

The Food and Drug Administration (FDA) has released guidance stating that it has no intention to regulate medical device data systems (MDDS), medical image storage devices, and medical image communication devices “due to the low risk they pose to patients and the importance they play in advancing digital health.”  The guidance has welcome implications for mHealth developers who were worried that these integral pieces of the patient monitoring ecosystem would fall under more stringent regulatory categories.

The FDA released its mobile medical applications guidance in September of 2013, which stated that the agency had no intention of foisting stringent regulations upon the majority of mobile health apps, but uncertainty over medical devices remained. Since working with the ONC and Federal Communications Commission (FCC) on its health IT framework, the FDA has reclassified these devices and programs from high-risk to low-risk, opening up more opportunities for innovation and development in the commercial market.

“It is important for the FDA to be well-equipped with the proper tools to be able to advance public health while taking care that innovation is not stifled through uncertainty or over-regulation,” wrote a bi-partisan group of Senators in March, urging more guidance on the issue.  “While the FDA’s final guidance has provided clarity on the agency’s approach to regulation of mobile medical applications, we believe more transparency is needed to avoid stakeholder confusion over how a wider range of medical software might be appropriately regulated.”

After taking time to deliberate and consult with industry experts, the FDA now believes “that medical device data system products pose little risk,” explains FDA Senior Policy Advisor Bakul Patel in an accompanying blog post. “While every medical device and procedure carries a certain level of risk, the health IT report proposes a risk-based framework – where we use our regulatory tools, resources, and expertise where they are most needed – and that’s with devices that carry greater levels of risk.”

“Medical device data systems are critical to the success of digital health because they transfer, store, convert, and display a variety of information from medical devices critical to understanding an individual’s health,” Patel added. “These systems are the foundation for intercommunication and interoperability among devices and between medical devices and other health IT.”




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