October 15, 2020

NRC and FDA Convene Workshop on Emerging Technologies

On October 14, 2020, the U.S. Nuclear Regulatory Commission (NRC) and Food and Drug Administration (FDA) convened a public workshop titled, “Enhancing Development of Emergency Technologies.” American College of Radiology® (ACR®) and American Society of Radiation Oncology representatives participated on the organizing committee for the virtual event.

The workshop explored the regulatory pathways that manufacturers and healthcare professionals navigate prior to the marketing and authorized use of new radiopharmaceuticals and medical devices/sealed sources. The common message for manufacturers and clinical investigators was that early dialogue and collaboration with NRC and FDA is key for enhancing consistency in the development of product specifications and instructions for use.

The ACR Commission on Medical Physics Government Relations Committee chair, Ralph Lieto, moderated the panel on radiological devices, which focused on products under FDA Center for Devices and Radiological Health and NRC oversight, such as yttrium-90 microsphere brachytherapy and certain newer gamma stereotactic radiosurgery units regulated under 10 CFR 35.1000. The panel discussed FDA’s total product life cycle approach to medical device oversight and NRC’s sealed source and device registry process.

Moving forward, the regulatory agencies will use the proceedings of the workshop and other discussions to inform initiatives within those agencies to better align their respective regulatory pathways. To that end, the FDA indicated that preclinical and clinical study requirements for radiopharmaceuticals are in the process of reexamination. Likewise, the NRC will initiate a rulemaking to address emerging technologies currently under 10 CFR 35.1000, including normalization of licensing requirements for emerging technologies that have reached maturity. As always, the ACR will remain active in any pertinent regulatory policy initiatives.