Devices

FDA Amends, Repeals Some Rad Health Regs

FDA says it is amending and repealing parts of the radiological health regulations covering recommendations for radiation protection during medical procedures, certain records and reporting for electronic products, and performance standards for diagnostic x-ray systems and their major components, laser products, and ultrasonic therapy products. The final rule says FDA is acting to clarify and update the regulations to reduce regulatory requirements that are outdated and duplicate other means to better protect health against harmful exposure to radiation-emitting electronic products and medical devices.

The changes are:

repeal the radiation protection recommendations that have become outdated and unnecessary;
remove or reduce some of the annual reports and test record requirements that are unnecessary or may duplicate other reporting requirements by FDA and state regulators;
revise the timing to provide for quarterly reporting for accidental radiation occurrences that are not associated with a death or serious injury;
amend the applications for variances processes to no longer require a manufacturer to submit two additional copies with the original documentation;
amend the regulations to no longer require assemblers who install certified components of diagnostic x-ray systems to submit reports of assembly to FDA;
amend the reporting requirements for manufacturers that incorporate a certified laser product to reduce reporting that is considered duplicative under certain conditions; and
repeal the performance standard for ultrasonic products because it is limited to a subset of physical therapy devices with an outdated standard.

“The agency believes the amendments and repeals will help to ensure that the requirements for radiation-emitting electronic products and devices will continue to protect the public health and safety while reducing regulatory burden,” the rule says.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome