On October 14, the U.S. Food and Drug Administration (FDA) released draft guidance entitled "Software as a Medical Device (SaMD): Clinical Evaluation" and invited interested parties to submit comments for consideration in the final version.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The draft guidance also describes an approach for categorizing SaMD based on the levels of impact on the patient or public health where accurate information provided by the SaMD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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