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FDA Proposal to Pull Some Radiological Health Regulations Draws Mixed Reactions

Posted 16 July 2019 | By Ana Mulero 

FDA Proposal to Pull Some Radiological Health Regulations Draws Mixed Reactions

A US Food and Drug Administration (FDA) proposal to amend and repeal parts of its radiological health regulations will enable better use of resources and reduce duplication, but clarifications are needed on the recording and reporting requirements, stakeholders argue.
 
The comment period on the March proposed rule closed earlier this month, with letters from industry groups AdvaMed and the Medical Imaging & Technology Alliance (MITA), as well as medical organizations the American Academy of Oral and Maxillofacial Radiology (AAOMR) and the American Association of Physicists in Medicine (AAPM), among others. Commenters generally support FDA’s Center for Devices and Radiological Health (CDRH) in its efforts to reduce the burden on manufacturers of electronic products and medical devices by minimizing recording and reporting requirements deemed unnecessary or duplicative of other requirements.
 
Revising the timing for submissions of accidental radiation occurrences (AROs) reporting requirements would create efficiencies, allow for cost savings and support patient access to electronic products and medical devices, according to commenters. The revision would allow quarterly summary reporting for AROs through the use of CDRH’s August 2018 voluntary malfunction summary reporting program, with the goal of harmonizing the two reporting types.
 
“We appreciate FDA’s proposal to provide for quarterly summary reporting for AROs that are not serious injuries or death,” AdvaMed vice president for technology and regulatory affairs Jamie Wolszon writes. This would allow FDA to “focus its resources on the events that are most likely to impact public health and more easily discern arising safety concerns.”
 
Yet AdvaMed member companies are reportedly confused as to whether an ARO report would still be needed even when a medical device report (MDR) is not. Wolszon says the group is “not aware of a scenario of an ARO that would not be captured by either the adverse event or malfunction prongs of MDR obligations” and requests additional clarity regarding the intersection between AROs and MDRs.
 
MITA welcomes the proposed changes to ARO requirements too. The ask of MITA executive director Patrick Hope is that FDA makes clear that manufacturers would no longer be subject to the document retention requirements for initial supplemental, abbreviated and annual reports.
 
Yet the AAOMR takes issue with the rulemaking’s reliance on states’ requirements as “several states have not updated their radiation and reporting requirements for electronic products and medical devices for over 30 or 40 years or defer to federal requirements.” Repealing such requirements in these states “may be catastrophic if a recall on ionizing radiation equipment were issued,” the group cautions.
 
The AAPM disagrees with the AAOMR as it believes that “state laws provide sufficient oversight for the safe use of medical x-ray modalities.” But the AAPM also urges FDA to remain vigilant.
 
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