The Food and Drug Administration (FDA) is seeking comments on a proposed rule to amend and repeal parts of the radiological health regulations covering recommendations for radiation protection during medical procedures, certain records and reporting for electronic products, and performance standards for diagnostic x-ray systems and their major components, laser products, and ultrasonic therapy products. The FDA is proposing this action to clarify and update the regulations to reduce regulatory requirements that are outdated and duplicate other means to better protect the public health against harmful exposure to radiation emitting electronic products and medical devices. The FDA is comprehensively reviewing existing regulations to identify opportunities for repealing and amending regulations that will result in meaningful burden reduction while allowing the Agency to achieve our public health mission and fulfill statutory obligations.
This proposed rule would amend and repeal certain regulations for radiation emitting electronic products and medical devices because FDA has identified the regulations as being outdated and duplicative of other means for reducing radiation exposure to the public. The FDA is proposing to update the regulations to reduce regulations that are outdated and otherwise clarify requirements for protecting the public health against radiation exposure from specific electronic products and medical devices. The regulations being proposed for amending or repealing are the radiation protection recommendations for specific uses, records and reporting requirements for electronic products, applications for variances, and performance standards for diagnostic x-ray systems and their major components, laser products, and ultrasonic therapy products.