FOR IMMEDIATE RELEASE
Tuesday, June 2, 2026
Contact:
Jeff Ruch (510) 213-7028 [email protected]
FDA Spurns CT Scan Reliability Safeguards
Current Lax Standards Put Patients at Risk and Pose Regulatory Violations
Washington, DC — The U.S. Food and Drug Administration (FDA) has rebuffed recommendations to improve clinically safe outcomes from the use of Computed Tomography (CT) imaging devices, put forward by Public Employees for Environmental Responsibility (PEER) and an FDA scientist. Today, PEER filed a formal appeal of that rejection.
Roughly 90 million CT scans are performed annually in the U.S., making it one of the most widely used diagnostic tools for detecting diseases like cancer. However, CT scans expose patients to radiation, which carries its own cancer risks.
FDA is promoting a software tool developed by its own laboratory to assess CT dose reduction percentages, while explicitly disclaiming the clinical relevance of the resulting percentages. Although FDA repeatedly acknowledged post-market data indicating that safe dose reduction was likely below 25%, it cleared devices with reductions ranging from 50% to 82%, at which image quality may be compromised and tumors or other abnormalities may be missed.
To defend the tool, FDA repeatedly said the tool used to clear dose reduction percentages was “not meant to indicate clinical levels of performance” and FDA “always knew [the tool] would give optimistic numbers” (i.e., percentages too high to be safe). The agency argued that it could therefore continue to use the tool in device clearance. In August 2025, PEER filed a complaint under the Information Quality Act on the grounds that this stance was irresponsible and clashed with FDA’s own regulatory and scientific integrity standards. It demanded that FDA withdraw its current recommendation and substitute new guidance to ensure clinical safety and effectiveness.
“The FDA has put its administrative convenience ahead of its legal and moral obligations,” stated PEER Senior Counsel Jeff Ruch, who filed the complaint on behalf of FDA scientist Dr. Xin He, who has tried for eight years to resolve the matter internally, but to no avail. “Health and Human Services Secretary Robert F. Kennedy has encouraged whistleblowers to come forward, but he has yet to listen to this one.”
Before PEER’s complaint, the issue had already undergone multiple internal FDA reviews, including decision memos signed by former device center director Jeff Shuren and former FDA Chief Scientist Namandje Bumpus. Yet FDA still took 270 days to deny the complaint, despite HHS guidelines requiring a 60-day response. Notably, FDA’s response did not engage with either the scientific evidence or the legal analysis of regulatory violations presented in the complaint.
“FDA’s regulatory and scientific evasion is just maddening,” remarked Dr. He, noting the ongoing risks of patient harm. “The agency spent eight years calling the tool ‘valid’ while avoiding the most basic questions: ‘What is it valid for?’ or even ‘What is the claim of the tool?’ After four decades of taxpayer-funded research, if the tool has any validity at all, FDA needs to put it in writing.”
Under its Information Quality Act guidelines, FDA is supposed to respond to this appeal “in a timely manner.”
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Read PEER request for reconsideration
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.