Wearables for Epilepsy: How FDA Regulates Seizure Monitoring and Which Devices Are on Record

How FDA classifies seizure-monitoring wearables

Non-EEG wearables that flag seizures fall under 21 CFR 882.1580, "Non-electroencephalogram (EEG) physiological signal based seizure monitoring system": "A noninvasive prescription device that collects physiological signals other than EEG to identify physiological signals that may be associated with a seizure." It is Class II with special controls, product code POS.

• Clinical testing must show the device functions "as an assessment aid for monitoring for seizure-related activity."
• "Performance measurements must include positive percent agreement and false alarm rate."
• Labeling is required for both clinicians and patients or caregivers, including instructions "regarding how to set the device threshold."

EEG devices are a separate regulation, 21 CFR 882.1400, with product codes including GWQ (full-montage standard EEG), OMC (reduced-montage EEG) and OMB (automatic event detection software for full-montage EEG).

Sources: 21 CFR 882.1580 (eCFR); openFDA classification, 882.1580; openFDA classification, 882.1400. This page is a summary, not medical or regulatory advice.

Devices on record under product code POS

The table is a partial list of POS premarket records, oldest first. It may miss devices under other codes, and we have not summarized intended use or performance: read each summary on FDA's database before stating what a device detects. Clearance or a De Novo grant is not FDA approval.

Sources: openFDA 510(k) records, POS; checked on the FDA 510(k) database and FDA De Novo database. openFDA describes its data as unvalidated.

Clinical guidance

The ILAE and IFCN published a joint clinical practice guideline on automated seizure detection using wearable devices in 2021. Its recommendations focus on tonic-clonic seizures; read the guideline itself for the exact scope before relying on it.

Source: Beniczky et al., Epilepsia 2021 (PubMed).

What it means for startups

Our reading (editorial, not from a source):

• A seizure-flagging wearable is a device, not a wellness product: prescription, Class II, with a 510(k) path under POS.
• Design the study around the required metrics. Positive percent agreement and false alarm rate need confirmed seizure events and enough recording time to estimate false alarms.
• Labeling seizures takes expert annotation: onset, offset and seizure type, with agreement checks between reviewers.
• Claims beyond the guideline's focus need their own evidence.

Related resources

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