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

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Kyle Dolinsky
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Karla Ballesteros
Associate
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Kaitlin Clemens
Associate

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Kyle Dolinsky
Partner
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Karla Ballesteros
Associate
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Kaitlin Clemens
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

Avatar
Kyle Dolinsky
Partner
Avatar
Karla Ballesteros
Associate
Avatar
Kaitlin Clemens
Associate

Get in touch

Avatar
Kyle Dolinsky
Partner
Avatar
Karla Ballesteros
Associate
Avatar
Kaitlin Clemens
Associate

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