Regulator Proposes Reducing Requirements For Radiation-Emitting Products

Author:Mr Randy Prebula, Jodi Scott, Lina R. Kontos and Arthur E. Kim
Profession:Hogan Lovells

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In the proposed rule, FDA noted a desire to clarify and update the regulations to help impacted industries by reducing outdated and duplicative regulatory requirements and to identify better ways to protect the public against exposure to radiation-emitting electronic...

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