FDA Proposes Radiological Health Deregulatory Action

Regulatory NewsRegulatory News
| 29 March 2019 | By Ana Mulero 

The US Food and Drug Administration (FDA) on Friday proposed to amend and repeal parts of the current radiological health regulations regarding certain recommendations, including radiation protection during medical procedures and performance standards for diagnostic x-ray systems.

The action sought via the new proposed rule also covers recommendations under the radiological health regulations on diagnostic x-ray systems’ major components, laser products, ultrasonic therapy products, as well as specific uses, records and FDA medical device reporting requirements for electronic products.

It is part of the agency’s implementation of the Trump Administration’s “one-in, two out” directive. FDA said it has proposed clarifications and updates to the regulations “to reduce regulatory requirements that are outdated and duplicate other means to better protect the public health against harmful exposure to radiation emitting electronic products and medical devices.”

Under the proposed rule, FDA is looking to repeal two parts of the radiological health regulations’ general provisions and amend four parts. A revision to allow accidental radiation occurrences not associated with a death or serious injury to be submitted on a quarterly basis is proposed as well.

The two parts that would be repealed, when and if the rule is finalized, relate to radiation protection recommendations and the performance standards for sonic, infrasonic and ultrasonic products.

FDA argued some of the recommended radiation protections and performance standards of the radiological health regulations are now “outdated and redundant” not just because of other federal and state requirements and current radiation guidance, but also due to recent voluntary consensus standards, such as the standards developed by the International Electrotechnical Commission.

The agency said it believes the amendments in the proposed rule will continue to protect the health and safety of the public while reducing regulatory burdens on both FDA and industry. These amendments propose to remove and reduce annual reports and test record requirements and reduce regulatory requirements on certain uncertified and uncertified laser products. They also seek to cease requiring manufacturers to submit copies with original applications for variances from provisions of performance standards and assemblers who install x-ray systems components to submit assembly reports to FDA.

The proposed rule comes amid FDA’s work to update 1989 regulatory policies for manufacturers of diagnostic x-ray equipment, with the release of draft guidance in December 2018.

Proposed rule


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