FDA final rule reduces radiological devices reporting requirements

Regulatory NewsRegulatory News | 20 January 2023 |  By 

FDA headquarters in White Oak, MD. (Source: FDA)

The US Food and Drug Administration (FDA) on Thursday issued a final rule that significantly reduces record-keeping requirements for medical devices such as x-rays. The agency said the move will substantially reduce the administrative burdens for itself and the medical device industry.
Following a public consultation, FDA announced a final rule on 20 January that amends and repeals some radiological health regulations for radiation protection during medical procedures. It also does the same for certain records and reporting requirements for electronic products and performance standards for diagnostic x-ray systems and their major components, lasers and ultrasonic therapy products. The agency said the move is meant to reduce regulatory requirements that are outdated and duplicative.
“Many of the requirements in our radiological health regulations are over 30 years old,” FDA said, noting that the reduced requirements will still enable it to ensure that public health and safety is protected.
FDA said it is removing or reducing annual reports and test record requirements for radiological products that may be duplicative of other requirements by FDA and state regulators. For instance, it has decided not to require quarterly reporting requirements for accidental radiation occurrences (ARO) reports that are not associated with deaths or serious injuries. Instead, they can be submitted annually.
FDA initially proposed the changes to its rules in 2019. Some of the stakeholders argued that quarterly reporting of AROs for cases that were not associated with death or serious injury were still needed. One commentator asked that medical devices that are also electronic products should only need to comply with FDA’s Medical Device Reporting (MDR) requirements and no more.
FDA said the ARO reporting program is intended to capture both serious malfunctions that require immediate action to prevent future death or injury, which overlaps with MDR requirements, but also less-serious events that do not.
“For this reason, FDA believes ARO reporting requirements should be maintained even when the product is subject to part 803 reporting requirements to ensure the protection of the public health and safety under the [Electronic Product Radiation Control] program,” the agency said in its rationale to keep the reduced ARO reporting requirement.
In addition, to reducing ARO reporting requirements, the agency has also amended the applications for variances processes to no longer require a manufacturer to submit two additional copies with the original documents meant to reduce administrative burdens. It will also no longer require assemblers who install certified components of diagnostic x-ray systems to submit reports of assembly to the agency.
Furthermore, FDA’s new rule also amends reporting requirements for manufacturers that incorporate a certified laser product to reduce reporting that is considered duplicative under certain conditions and repeals the performance standard for ultrasonic products because it is limited to a subset of physical therapy devices with an outdated standard.
FDA said the new rule is expected to save the agency almost $70M at a 7% discount rate or almost $98M at a 3% discount over 20 years. It expects to save more than $6.5M annually.


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