FDA 510(k) Premarket Notification — Medical Devices

Unregulated Class II devices posed safety risks to US consumers.

Key Obligations

["Submit 510(k) before marketing Class II devices", "Demonstrate substantial equivalence to predicate device", "Register establishment with FDA", "List device in FDA database"]

Penalty Ranges

{"civil": "Up to $15,000 per violation, $1M total", "seizure": "Product seizure and injunction"}

Mandatory Deadline: Before market entry

Affected HS Codes: ["90"]

Issuing Authority: U.S. Food and Drug Administration (FDA) / CDRH