CHIME wrote its letter in response to the Clinical and Patient Decision Support Software draft guidance the FDA released in December. The draft guidance attempts to clarify what types of CDS and PDS software the FDA defines as a “medical device” in need of agency oversight.
Under the FDA’s draft guidance, software that allows a user to “independently review” the basis for its recommendations are excluded from FDA regulation, such as CDS that suggests clinicians order particular tests consistent with existing guidelines.
“Overall, we are supportive of much of the draft FDA has published,” the letter reads. “There are three areas, however, where we recommend changes.”
CHIME’s recommendations centered on what software is included under the FDA’s purview. In particular, the group suggested the FDA reframe definitions to ensure intensive care unit dashboards and EHRs are excluded from agency oversight.
“EHRs as a whole should not be regulated just because one function within the EHR is considered a device; rather, the focus should be on the individual function,” the group noted.
To access CHIME’s letter, click here.
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