USA – FDA Proposes Radiological Health Deregulatory Action

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 FDA said it has proposed clarifications and updates to the regulations “to reduce regulatory requirements that are outdated and duplicate other means to better protect the public health against harmful exposure to radiation emitting electronic products and medical devices.”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…