Devices

Cotton Introduces Bill Targeting Chinese-Made Medical Devices

Sen. Tom Cotton (R-AR) has introduced legislation that would require FDA to review and potentially recall Chinese-manufactured networked medical devices deemed to pose cybersecurity risks to American patients. The proposed legislation, titled the Countering Chinese Cyberthreats for Patients (Countering CCP) Act, would direct FDA and the Cybersecurity and Infrastructure Security Agency (CISA) to conduct a retrospective review of Chinese-made connected medical devices currently in use in the U.S.

According to Cotton, the bill is intended to address concerns that medical devices manufactured in China could expose sensitive patient information or create cybersecurity vulnerabilities within the U.S. healthcare system. "Communist Chinese-made medical devices threaten the privacy and safety of every American patient," Cotton said in a statement announcing the legislation. "My bill would crack down on these dangerous devices."

Under the proposal, FDA would be required to recall Chinese-made networked medical devices identified as posing cybersecurity risks to patients or healthcare providers. The legislation would also require HHS and CISA to submit a report to Congress assessing the cybersecurity preparedness of the U.S. medical device industry, the market share of Chinese-made medical devices in the U.S., and strategies to strengthen domestic cybersecurity protections.

The bill follows a May letter from Cotton to FDA (see story) urging heightened scrutiny of Chinese-manufactured medical devices after the agency issued a recall notice related to the Contec CMS8000 patient monitor. Federal cybersecurity officials previously warned that certain versions of the device contained functionality that could create cybersecurity vulnerabilities.

The legislation reflects growing congressional concern about the security of connected medical technologies and broader efforts to reduce U.S. reliance on Chinese-manufactured healthcare products and critical technologies.

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