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

  • Posted by: inetika
  • Category: GLOBAL NEWS

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).