The FDA released a final guidance Sept. 28 on what kinds of decision support software it intends to regulate.
The FDA spelled out four criteria that determine whether things like artificial intelligence software that flags medical conditions for physicians are considered diagnostic devices that must be reviewed by the agency.
Criteria that makes your software a device, according to the FDA:
- If your device provides risk scores for diseases or conditions, probability for diseases or conditions, and time-critical outputs.
- If your device acquires, processes or analyzes signal acquisition systems, MRIs, next-generation sequencing, glucose monitoring or computer-aided diagnosis.
- If your device acquires, processes or analyzes continuous signals, medical images, waveforms or continuous patterns.
- If your device provides a basis of recommendation.