FDA Final Rule for Diagnostic X-Ray, Laser Products, and Ultrasonic Products

Published: 02/21/2023

  • Food and Drug Administration
Relevant To:
  • Critical Access Hospitals,
  • Hospitals

The U.S. Food and Drug Administration (FDA) final rule, Radiological Health Regulations: Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-ray, Laser and Ultrasonic Products, is effective as of February 21, 2023. According to the FDA, the final rule will help ensure the requirements for radiation emitting electronic products and medical devices continue to protect the public health and safety while reducing unnecess

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