Medical Device Software Storing Data Excluded From FDA Review

April 16, 2021, 1:41 PM

Software that stores, transfers, or displays clinical lab tests or other medical data is excluded from FDA regulations governing medical devices, according to a final rule released Friday.

The Food and Drug Administration’s rule (RIN 0910-AH67) amended descriptions in eight instances to conform to a provision in the law that says medical software that encourages a healthy lifestyle and is unrelated to the diagnosis or treatment of a disease or condition isn’t required to undergo FDA review. The law also says health facilities’ administrative support systems that track billing and claims information or appointment schedules aren’t considered medical devices.


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