On October 14, the U.S. Food and Drug Administration (FDA)
released draft guidance entitled "Software as
a Medical Device (SaMD): Clinical Evaluation" and invited
interested parties to submit comments for consideration in the
final version. The document was produced by the International
Medical Device Regulators Forum (IMDRF), an organization formed to
provide international harmonization of medical device regulatory
requirements. The guidance is intended to establish a common
understanding of clinical evaluation and principles for
demonstrating the safety, effectiveness, and performance of
stand-alone software intended for medical purposes.
IMDRF defines SaMD as "software intended to be used for
one or more medical purposes that perform these purposes without
being part of a hardware medical device." SaMD generally does
not have direct contact with patients but rather performs
computation on data input and provides data output to facilitate
clinical management, diagnosis, or treatment by the clinician user.
Although there is no direct patient contact, decisions made in
reliance on SaMD output directly impact patient outcomes.
The FDA guidance addresses the unique challenge of demonstrating
clinical effectiveness notwithstanding the indirect contact between
the patient and the SaMD. The guidance also seeks to leverage the
inter-connectivity of the SaMD, which allows manufacturers to
implement changes and modifications more quickly and efficiently
using "real world" performance information.
The document guides SaMD assessment by defining three types of
evidence required for a clinical evaluation:
- scientific validity (evidence of an association between the SaMD output and a clinical condition),
- analytical validity (evidence of technical performance related to accuracy, reliability, repeatability, and reproducibility), and
- clinical performance (evidence of the ability of the SaMD to yield clinically meaningful output associated to the target use of SaMD output in the health care situation).
The draft guidance also describes an approach for categorizing
SaMD based on the levels of impact on the patient or public health
where accurate information provided by the SaMD to treat or
diagnose, drive clinical management, or inform clinical management
is vital to avoid death, long-term disability, or other serious
deterioration of health. Among other enumerated issues, the FDA is
seeking comments related to whether the document appropriately
addresses the scope of SaMD and how the proposed framework would
impact currently regulated devices, including potential adverse
consequences.
The FDA guidance incorporates by reference earlier IMDRF guidance
documents pertaining to the regulation of SaMD which were not open
to notice-and-comment by the FDA. The FDA has invited interested
parties to submit comments to docket number FDA-2016-D-2483 by
December 13, 2016
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