Dive Brief:
- The Food and Drug Administration released new draft guidance on evaluating software as a medical device.
- The document details the principles for a SaMD and the goals of evaluation, which include establishing the "scientific validity, clinical performance, and analytical validity," the agency wrote.
- Public comment on the draft guidance will be accepted until by Dec. 13, 2016.
Dive Insight:
The FDA's aim to increase evaluation of medical software comes just after related efforts by the HHS' Office of the National Coordinator for Health Information Technology (ONC) to increase oversight of certified health information technology. That move has drawn some criticism among industry stakeholders concerned the ONC may be overstepping its bounds and that its actions may be unnecessary in light of the FDA's related efforts.
What is specific in this FDA guidance is its attention to SaMD, which it defines as "software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device." In the case of such software, which runs on general purpose computing platforms, the risks to public health do not include any direct contact with patients, but rather stem from how data output from the software may impact the clinical management patients.
The FDA noted that over the past several years there have been numerous initiatives by regulatory authorities and industry stakeholders to foster a unified international approach, and that the current draft guidance was prepared under the auspices of the International Medical Device Regulators Forum (IMDRF).