Draft Guidance: FDA Does Not Intend to Enforce Compliance for Medical Device Data Systems

​The U.S. Food and Drug Administration (FDA) 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low risk they pose to patients and the importance they play in advancing digital health, according to June 20, 2014, draft guidance from FDA. Medical device data systems are hardware or software products that transfer, store, convert formats of, and display medical device data. They do not modify the data or control the functions or parameters of any connected medical device, and they are not intended to be used in connection with active patient monitoring. Medical device data systems were reclassified from class III (high risk) to class I (low risk) in 2011. Since then, FDA has gained additional experience with these types of technologies and has determined that they pose a low risk to the public.