FDA Proposes Updates to List of Class II Exempt Devices

The U.S. Food and Drug Administration (FDA) has proposed updates to its list of certain medical devices exempt from its premarket notification requirements.

According to a Notice published in the Federal Register in late October, the FDA is considering adding the following Class II device types to its list of devices exempt from its 510(k) review procedures:

  • Assisted reproduction laminar flow workstations (product code MQG)
  • Phosphate-buffered saline used as a reproductive media (product code MQL)
  • Instruments designed for press-fit osteochondral implants (product code QBO)
  • Prescription-only interactive rehabilitation exercise devices (product code LXJ)
  • Prescription-only therapeutic massage equipment used in connection with the pelvic floor musculature (product code OSD)

Read the FDA’s proposed updates to the list of Class II exempt devices as published in the Federal Register. Comments on the proposed changes must be submitted to the FDA by not later than December 24th.

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