AI/ML SaMD Improvements
According to the paper, if the AI/ML SaMD has a modification related to an algorithm design and requires re-training with a new data set, a new premarket submission may not be necessary. There are three types of modifications that fit this description:
- Performance — to improve the performance of the SaMD, such as increasing its sensitivity, while not altering the intended use of the device or the input type
- Inputs — increasing the compatibility of the SaMD and increasing the input data type, including analysis of oximetry data and heart rate data without changing the intended use.
- Intended Use Changes — changing the significance of the information, such as from driving clinical management to treating or diagnosing and/or changing in the healthcare situation or condition to from non-serious to serious, for example.
Traditionally, the above modifications would trigger the need for a new 510(k).
The paper highlights how anticipated performance and input changes could be described in a premarket submission by outlining the associated Algorithm Change Protocol (ACP). The ACP would detail the specific methods to be used in achieving the anticipated modifications and manage any new risk.
Industry and Physician Public Comments
The comment period on the discussion paper closed in early June. There were more than 100 comments, most of which are public.
AdvaMed and the Combination Products Coalition (CPC) praised the agency for developing a regulatory approach but offered a number of recommendations for the agency to consider as it works on a potential draft guidance.
The AMA said it does not want physicians penalized who do not use AI systems while regulatory oversight, standards, clinical validation, clinical usefulness, and standards of care are in flux. The group opposes mandates by payers, hospitals, health systems, or governmental entities mandating the use of health care AI systems as a condition of licensure, participation, payment, or coverage.
Next?
Gottlieb said the agency has more work to do to build out this initial set of ideas and will rely on comments and feedback from experts and stakeholders to help inform the agency as it continues to think about how it regulate artificial intelligence technologies to improve patient care.
“We anticipate several more steps in the future, including issuing draft guidance that’ll be informed by the feedback on [the] discussion paper.”
