FDA Issues Updated Guidance Loosening Regulatory Approach to Certain Digital Health Tools

Lexology January 15, 2026
Latham & Watkins LLP

Two updated guidance documents aim to reduce “red tape” for certain digital health products.

KEY POINTS

• The updated guidance expands the scope of digital health tools, including certain types of wearables or clinical decision support software, that are legally exempt or otherwise free from FDA medical device oversight.
• The changes provide commercial opportunities for developers and manufacturers whose product offerings may previously have fallen outside the scope of FDA’s interpretation of the CDS exemption or general wellness policy.

On January 6, 2026, the Food and Drug Administration (FDA) issued updates to its guidance documents governing clinical decision support (CDS) software¹ and general wellness devices.² FDA Commissioner Marty Makary touted these changes as a way for FDA to “get...

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