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In January 2023, the U.S. Food and Drug Administration (FDA) published the 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.
This rule goes into effect today. This 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 unnecessary regulatory burdens.
The Final Rule:
- Removes recommendations in the regulations that have become outdated or duplicative to more current recommendations by the FDA, industry, and professional societies.
- Amends and repeals certain records and reporting requirements for electronic products, including reporting for diagnostic x-ray systems and lasers that are unnecessary or duplicative of other reporting requirements by the FDA.
- Amends the reporting requirements for manufacturers that incorporate a certified Class I, II, or IIIa laser product to the reduce reporting that is considered duplicative under certain conditions.
For consistency with the amended regulations, the FDA has updated certain Radiation Emitting Product web pages and guidance.
Questions?
If you have questions about this final rule, contact the Radiological Health Program at RadHealth@fda.hhs.gov.
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