LS&HC Horizons 2023 - Flipbook - Page 16
Hogan Lovells | 2023 Life Sciences and Health Care Horizons | Clinical Trials
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Updates to FDA’s CDS guidance pose new challenges
for some software manufacturers
On 28 September 2022, FDA issued the
update to its draft guidance document, Clinical
Decision Support Software. The final guidance
establishes FDA’s current views on regulation
of “clinical decision support” (CDS) software
– tools that assist clinicians by analyzing
patient data and generating corresponding
notifications or recommendations. These
range from simple automations of clinical
calculations to proprietary artificial intelligence
(AI)-based algorithms.
The guidance expands upon FDA’s pre-existing
interpretation of which CDS functions are
regulated medical devices versus which CDS
functions fall outside of FDA’s jurisdiction
(non-device CDS). The evaluation framework
remains guided by the governing statute and
based on the intended use and perceived risk
(consistent with how FDA regulates all
medical devices).
Kelliann H. Payne
Partner, Philadelphia
However, FDA added significant nuance to
the criteria for qualifying as non-device CDS,
which while providing greater clarity on
their application, results in extending FDA’s
authority over more CDS products. This poses
challenges for industry with currently marketed
products that have historically not been actively
regulated by FDA. In particular, FDA asserted
that any CDS function which issues an output
that is (a) related to a time-critical decision,
and/or (b) susceptible to automation bias
(i.e., provides insufficient opportunity for
health care professionals to input their own
judgment into the clinical decision-making),
is likely to be regulated as a medical device.
The agency also removed enforcement
discretion for patient-facing CDS functions.
Hogan Lovells is working with clients to
determine their current FDA obligations and
plans for adapting in light of the new guidance.
Jodi Scott
Partner, Denver
Suzanne Levy Friedman
Counsel, Washington, D.C.
