FOR IMMEDIATE RELEASE
Thursday, August 7, 2025
Contact:
Jeff Ruch (510) 213-7028 [email protected]
FDA Ignores CT Scan Misdiagnosis Risks
Complaint Faults FDA Failure to Address Post-Market Warnings
Washington, DC — The U.S. Food and Drug Administration (FDA) has cleared CT imaging devices using a recommendation the agency itself acknowledges is not meant to assure clinically safe outcomes, according to a complaint filed today by Public Employees for Environmental Responsibility (PEER) on behalf of an FDA scientist. The complaint details how the agency is aware of these serious safety concerns and yet has taken no corrective action.
Roughly 90 million CT scans are performed annually in the U.S. While essential for detecting diseases like cancer, these scans expose patients to radiation, which carries its own cancer risks. To minimize exposure, manufacturers have developed software designed to preserve image quality that is critical for detecting early-stage disease while reducing dose balance.
The FDA has cleared CT devices claiming dose reductions of 50 to 82% without compromising image quality. However, post-market data from 2018 suggest that safe dose reduction is likely below 25%, raising serious concerns about misdiagnosis in cleared devices, especially following a reported adverse event in which a patient was harmed. That clearance recommendation states that “Users should be aware that a radiation dose reduction level… does not transfer directly to clinical tasks on specific patients.”
The complaint was filed on behalf of an FDA scientist who has tried to resolve the matter internally or at least obtain permission for an internal scientific discussion, to no avail. The scientist recently resubmitted this complaint to the FDA’s new leadership, following Secretary Robert F. Kennedy Jr.’s call for FDA whistleblowers to come forward, only to have it dismissed once again.
“The risks with these devices are real, but what’s more troubling is a regulatory practice that is immune to evidence and accountability,” said the FDA scientist, pointing out that in the dispute resolution decision letters, the agency conceded the safety concerns but defended its position by stating that the dose reduction percentages are not meant to have clinical relevance. “This is not a responsible regulatory position.”
Citing multiple federal law and regulation violations, today’s complaint, filed under the Information Quality Act, demands that FDA withdraw its current recommendation and affirmatively flag the issue with information to assure clinical safety and effectiveness.
“The FDA has a legal obligation to assure the safety and effectiveness of medical devices,” said PEER Senior Counsel Jeff Ruch, noting that the agency has 60 days to respond to the complaint. “Although the FDA has repeatedly acknowledged safety concerns, it has taken no meaningful action to protect patients and therefore cannot provide the assurances it is required to extend.”
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Look at FDA’s internal dispute resolution process
PEER protects public employees who protect our environment. We are a service organization for environmental and public health professionals, land managers, scientists, enforcement officers and other civil servants dedicated to upholding environmental laws and values. We work with current and former federal, state, local and tribal employees.
