The U.S. Food and Drug Administration announced the availability of a draft guidance for the clinical evaluation of software as a medical device (SaMD). The draft guidance was prepared by the SaMD Working Group of the International Medical Device Regulators Forum (IMDRF), an international group of medical device regulatory authorities including the FDA. When finalized by the IMDRF, the draft guidance will represent the FDA’s “current thinking” on SaMD clinical evaluation and will not be binding.

SaMD is defined in the guidance as software that functions as a medical device and can run on a general purpose computing platform, “without being part of a hardware medical device.” Unlike other medical device-related software, SaMD primarily has risks associated with incorrect output affecting clinical management of a patient, rather than risks resulting from direct patient contact. Thus, the guidance is intended to address the “uniqueness of indirect contact between patients and SaMD” and provide globally harmonized principles for establishing scientific validity, clinical performance, and analytical validity for a SaMD.

The FDA is seeking public comment on the draft guidance generally, and related to eight specific issues:

  1. Does the document address the intention captured in the introduction/scope or vice versa?

  2. Does the document appropriately translate and apply current clinical vocabulary for SaMD?

  3. Are there other types of SaMD beyond those intended for non-diagnostic, diagnostic and therapeutic purposes that should be highlighted/considered in the document?

  4. Does the document adequately address the relevant clinical evaluation methods and processes for SaMD to generate clinical evidence?

  5. Are there other appropriate methods for generating clinical evaluation evidence that are relevant for SaMD beyond those described in the document?

  6. Are the recommendations related to the “importance of clinical evidence and expectations” appropriate as outlined for the different SaMD categories?

  7. Are the recommendations related to the “importance of independent review” appropriate as outlined for the different SaMD categories?

  8. Given the uniqueness of SaMD and the proposed framework—is there any impact on currently regulated devices or any possible adverse consequences?

The draft guidance is available for comment until December 13, 2016.