Why can some US-marketed health software claim disease risk without FDA medical device approval?

Question

I have seen a company marketing its software product in the US, making statements about disease risks (for example, providing cardiovascular or cancer risk scores) directly to consumers. However, they do not appear to have FDA approval as a medical device.
According to my reading of FDA guidance, software providing such risk scores would typically require medical device classification and approval. Why are some companies able to make these claims without being classified as medical devices by the FDA? Is there an exemption or loophole being used?
I am interested in understanding the regulatory rationale, especially when products are marketed directly to consumers and make statements that could influence health behavior or decisions.

Dr. Oliver Eidel · Accepted Answer

The FDA decides if software is a medical device based on its intended use and the specific claims it makes. Here are some reasons why a product might not require FDA approval, even if it provides disease risk information:
• Wellness Exception: If a product claims to support general wellness (like encouraging a healthy lifestyle) and does not diagnose or treat diseases, it can avoid being classified as a medical device. Some companies use careful wording to stay within this 'wellness' category, even if they mention risks.
• Informational Disclaimers: Companies may include disclaimers stating their product is for informational purposes only and not for clinical decision-making. If the output is not used by healthcare professionals or is not intended for diagnosis/treatment, the FDA may not regulate it as a device.
• Enforcement Lag: Sometimes, the FDA has not yet acted on a product, or it is flying under the regulatory radar. This can mean products are on the market even if they arguably should be regulated.
• Transparency of Data: If a company is transparent about how scores are generated and does not make concrete medical claims, they may avoid the 'medical device' label.

Despite these strategies, it's a gray area—if the claims are too strong or the product influences medical care, the FDA could still step in.

Why can some US-marketed health software claim disease risk without FDA medical device approval?

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