3/18/2026 8:36:05 PM | less than a minute read

FDA's 2026 Guidance on General Wellness Devices: Policy for Low-Risk Devices

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Kyle Dolinsky

Partner

Karla Ballesteros

Associate

Kaitlin Clemens

Associate

+1 more...

Get in touch

Kyle Dolinsky

Partner

Karla Ballesteros

Associate

Kaitlin Clemens

Associate

Samarth Parikh

Associate

FDA's 2026 general wellness guidance narrows device regulation for low-risk trackers but leaves significant privacy, security, and litigation risks.

Physician using laptop with FDA approved interface icons, symbolizing regulatory compliance, drug safety, and medical device certification for healthcare and pharmaceutical industry.

Get in touch

Kyle Dolinsky

Partner

Karla Ballesteros

Associate

Kaitlin Clemens

Associate

+1 more...

Get in touch

Kyle Dolinsky

Partner

Karla Ballesteros

Associate

Kaitlin Clemens

Associate

Samarth Parikh

Associate

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