Apps can now be classified as ‘medical device’

The US Food and Drug Administration has issued a final rule that reclassifies certain software and hardware products used with medical devices as Class I or low-risk products. Until now, these devices were considered to be either Class III (high-risk) devices requiring pre-market approval or accessories to an existing medical device.

The low-risk classification means these products will be exempt from pre-market review, but will still be subject to quality standards. The reclassification will come into effect on 18 April.

Known as Medical Device Data Systems or MDDS, these products are off-the-shelf or custom hardware or software that can be used alone or in combination with other devices. MDDS are used for displaying unaltered medical device data or transferring, storing or converting medical device data for future use, in accordance with a pre-set specification.

Examples include devices collecting and storing data from a glucose meter for future use and devices that transfer lab results to be displayed at a nursing station for future use.

The FDA had earlier indicated plans for lowering the risk classification of these products as an MDDS by itself does not provide any diagnostic or clinical decision making functions. In its final rule, the agency clarifies that an MDDS is not intended to be used in connection with active patient monitoring.

The downscaling of the classification level, the FDA says, is a common sense regulatory approach that provides clarity and predictability for manufacturers of these data systems.

Originally published on


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