FDA Plans to Exempt Five Class II Devices From Premarket Notification

November 1, 2019

The FDA is proposing to exempt additional Class II medical devices from 510(k) premarket notification requirements.

The 21st Century Cures Act requires the agency to publish a notice in the Federal Register listing each type of Class II (special controls) device that no longer requires a 510(k) application. In the latest notice, the agency lists five device types: an optical position/movement recording system, an internal therapeutic massager, an accessory used in assisted reproduction, an instrument for press-fit osteochondral implants, and a phosphate buffered saline solution.

All but one of the device types will receive partial exemptions. For example, the optical positioner’s exemption is for prescription-only devices, while the assisted reproduction accessory exemption is limited to assisted reproduction laminar flow workstations.

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