FDA Proposal to Reduce Burdens on Low-Risk Radiation Emitting Products Like Microwaves and Ultrasonic Devices

On April 1, 2019, the U.S. Food and Drug Administration (FDA) published a proposed rule to reduce and eliminate outdated and unnecessary records and reporting requirements for an array of non-medical electronic products that emit radiation such as microwaves, lasers, television receivers, and non-medical ultrasound products. (84 FR 12147).[1]

The proposed rule also covers medical devices extensively. This alert focuses on the impacts on non-medical electronic products.

The WELL

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