The Food and Drug Administration has issued draft guidance informing industry that the agency does not intend to enforce compliance with the regulatory controls that apply to medical device data systems, medical image storage devices, and medical image communications devices, due to the low risk they pose to patients.

“In 2011, FDA issued a regulation down-classifying medical device data systems. Since that time, FDA has gained additional experience with these types of technologies, and has determined that these devices pose a low risk to the public,” writes Bakul Patel, senior policy advisor in FDA’s Center for Devices and Radiological Health, in a June 20 blog.

Medical device data systems can collect and store data from a variety of other medical devices, including glucose meters, blood pressure cuffs, and weight scales. This data can be used at home to track certain information or it can be stored for a doctor to review at a later time. In addition, medical device data systems can be used in hospitals to collect information and data from other medical devices including bedside monitors and infusion pumps. This information can then be stored in a patient’s EHR for a more complete review of a patient’s total health.

“FDA’s regulatory oversight of health IT products is focused on the devices that pose higher risk to patients,” says Patel, who argues that this FDA guidance will encourage greater innovation in the development and maturation of these systems.

“That's a big change,” comments Bradley Merrill Thompson, an attorney at Washington, D.C.-based law firm Epstein Becker Green who counsels medical device companies on FDA regulatory issues. “This guidance is consistent with the notion that FDA is getting out of the broad health IT management sphere, and leaving that to ONC. I think they decided that the risk simply isn't there for FDA style controls, and that ONC voluntary standards are more consistent with the risk level.”

“I'm pretty bothered that they are choosing to do this through a guidance document,” Thompson adds. “That's a sloppy way to regulate. There is a regulation on the books that needs to be changed. I'm tired of FDA avoiding the proper legal channels to do this sort of thing. On the one hand, I appreciate the desire for speed, but I hope they do follow this up with a rulemaking very quickly.”


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