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  • Regulatory Update

US FDA Issues Final Rule to Streamline Radiological Health Regulations

US FDA formally proposes aligning Quality System Regulations with ISO 13485

January 25, 2023

The US FDA issued a final rule to streamline the radiological health regulations and clarify certain provisions, effective February 21, 2023. Some notable changes include:

  • Repealed the performance standard for ultrasonic products and radiation protection recommendations for specific uses.
  • Revised timing of submissions of reporting accidental radiation occurrences (AROs) allowing manufacturers to submit quarterly summary reports of AROs that are not associated with a death or serious injury and not required to be reported under the medical device reporting regulations (§ 1002.20; part 803).
  • Manufacturers are no longer required to submit two additional copies of applications for variances process (§ 1010.4(b)).
  • Reduced reporting requirements, under certain conditions, for manufacturers that incorporate a certified laser product.
  • Removed requirements for manufacturers to report model numbers of new models of a model family that do not involve changes in radiation emission or requirements of a performance standard in quarterly updates to their annual reporting (§ 1002.13(c)).
  • Assemblers who install certified components of diagnostic x-ray systems are no longer required to submit a report of assemblies, Form FDA 2579, to CDRH and instead will only be required to submit such reports to purchasers and applicable State agencies.
  • Amended applicability of the recordkeeping requirements for dealer and distributor records (§ 1002.40 and §1002.41).

Emergo by UL will post updates as they become available.