FDA issues final order exempting certain devices from 510(k) requirements

Five distinct device types will no longer require premarket notification (510(k)s) to the US Food and Drug Administration (FDA) according to a final order issued by the agency.

The following five device types were identified in the 22 July 2020 edition of the Federal Register:

• Assisted reproduction accessories (assisted reproduction laminar flow workstations);
• Reproductive media and supplements (phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; water for assisted reproduction applications);
• Orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation;
• Measuring exercise equipment (optical position/movement recording systems, measuring exercisers or interactive rehabilitation exercise devices for prescription-use only); and
• Internal therapeutic massagers (prescription-use only massagers that incorporate a quantitative feedback mechanism and a disposable covering).