January 20, 2023 — Today, 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.
Facts About the Final Rule
The final rule amends and repeals parts of the radiological health regulations, including to:
- Remove recommendations in the regulations that have become outdated or duplicative to more current FDA, industry, and professional society recommendations;
- Amend and repeal 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; and
- Amend the reporting requirements for manufacturers that incorporate a certified Class I, II, IIIa laser product to reduce reporting that is considered duplicative under certain conditions.
The FDA believes the amendments and repeals will help ensure that the requirements for radiation emitting electronic products and medical devices will continue to protect the public health and safety against harmful exposure to radiation emitting products and medical devices while reducing regulatory burdens.
The effective date for the final rule is 30 days following publication in the Federal Register. On the effective date of the final rule, we intend to update a number of CDRH guidances and webpages to reflect these changes to the radiological health regulations.
For more information: www.federalregister.gov