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Medical Devices / Submissions and Approvals

FDA Proposes Rule on Radiation Protection

April 1, 2019
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The FDA published a proposed rule that would update requirements for radiation-emitting medical devices as part of the agency’s effort to reduce the burden of regulatory compliance.

 Among other changes, the agency proposes to amend the records and reporting requirements by removing or reducing some of the annual reports and test record requirements that are unnecessary or that duplicate other reporting requirements by the FDA and state regulators.

The proposed rule also would revise the timing for submissions of reporting requirements for accidental radiation occurrences (AROs) to allow quarterly reporting for AROs that are not associated with a death or serious injury.

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