Challenges & Opportunities in Emerging Digital Health Technologies
ISPE
OCTOBER 27, 2022
There are important considerations if the DHTT is classified as a medical device, which may change the level of regulatory controls and evidentiary requirements to support its appropriate use, such as off-label versus on-label use of a device with prior marketing authorization. Is the software MDSW according to MDCG 2019-11?
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