Headache devices avoid heavy regulation in new FDA rule

The FDA downgrades non-invasive headache treatment devices to Class II controls, allowing them to skip the more stringent premarket approval pathway for medical devices.

The FDA agreed to downgrade headache treatment devices to a lower-risk classification, allowing new devices to reach the U.S. market with less-stringent oversight.

The devices went from Class III controls for high-risk devices, requiring premarket approval, to Class II controls for moderate-risk devices, reviewed through the fast-track 510(k) review pathway.

Food & Drug Administration (FDA), STX-Med

News Well, Regulatory/Clearance, 510(k), Food & Drug Administration (FDA), Neuromodulation/Neurostimulation, Regulatory/Compliance

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