The Food and Drug Administration (FDA) issued a proposed 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,” on April 1, 2019. The FDA is accepting comments on this proposed rule until July 1, 2019; at that time, the FDA plans to review and address these comments prior to releasing the final rule.
The proposed rule addresses existing regulations (21 CFR Parts 1000 to 1050) for certain medical devices and radiation emitting electronic products that are used in clinical settings. This includes new guidelines for the amount of protection required for patients during medical procedures that involve exposure to radiation and altering performance standards for diagnostic x-ray devices, products using lasers, and ultrasonic therapy devices. The FDA states in this proposed rule that these efforts are meant to address outdated and duplicative guidelines that are currently set in place. Additionally, the rule explicitly states that these actions are part of the FDA’s implementation of two Executive Orders (EO), EO 13771 and EO 13777, which were issued in January 2017 and February 2017, respectively.
Generally, the proposed changes in regulation require a reduction in the submission of reports and repealing of certain performance standards for these medical devices. The FDA justifies these revisions by stating that some current regulations are either not necessary for public health and safety, or outdated and redundant when considering other federal and state requirements. The regulations and standards addressed in this proposed rule were issued between 1976 and 2005.
The devices and products covered under this proposed rule emit ionizing radiation. According to the Environmental Protection Agency, exposure to ionizing radiation can have adverse effects on an individual’s health, including by potentially damaging genetic material. In particular, exposure to ionizing radiation is thought to increase the likelihood of developing some types of cancer, as indicated by studies that correlate individuals with high rates of ionizing radiation exposure (e.g., Japanese atomic bomb survivors) to an increased risk of developing certain types of cancer. According to Harvard Health, however, the benefits of these medical imaging techniques often outweigh the risks associated with radiation exposure as long as these tests are used only when appropriate and the frequency is tracked carefully by a physician.