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.