In a welcome move, on 1 April 2019 the U.S. Food and Drug Administration (FDA) proposed reducing regulatory requirements for a number of radiation-emitting electronic products, including radiation-emitting medical devices.
The current radiological health provisions under 21 Code of Federal Regulations Subchapter J have largely been in place and intact for nearly 40 years, with FDA issuing only a limited number of guidance documents in that time to refine the agency's approach to implementing these provisions. In the proposed rule, FDA noted a desire to clarify and update the regulations to help impacted industries by reducing outdated and duplicative regulatory requirements and to identify better ways to protect the public against exposure to radiation-emitting electronic products. In discussing the evolution of the regulatory landscape around these products, FDA also pointed to more modern ways to ensure patient and consumer safety, including measures for accountability promulgated by external stakeholder groups, states, voluntary consensus standards, and national health care organizations.
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