Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices – Draft Guidance for Industry and Food and Drug Administration Staff – FDA – 20 June 2014
“Thanks to advances in digital health, doctors and their patients are more frequently using computer systems to collect medical data that can provide useful information on a patient’s health.
Some of these systems, referred to as “medical device data systems,” are off-the-shelf or custom hardware or software products that transfer, store, convert format, and display medical device data without modifying it, and without controlling or altering the functions or parameters of any connected medical devices.
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.
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 electronic health record for a more complete review of a patient’s total health.
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.
Today, given the low level of patient risk, we are proposing a compliance policy under which medical device data systems should see their burdens reduced.
Why would we do that?”
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