FDA Proposes Risk-Based Clinical Decision Support Software Rules
The Food and Drug Administration has released revised draft guidance on how it proposes to regulate clinical decision support software, after facing industry criticism of its 2017 draft guidance.
- The Food and Drug Administration (FDA) has released revised draft guidance on how it proposes to regulate clinical decision support software, after facing industry criticism of its 2017 draft guidance.
The FDA is focusing on a risk-based approach to clinical decision support (CDS) software based on the risk to patients if the software malfunctions.
The agency explained that the draft guidance makes clear what types of CDS software would be subject to FDA regulation, what types of CDS software would not be regulated due to the low risk to patients, and what CDS types would not qualify as a medical device.
