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# Senator Concerned About Cybersecurity and Chinese Devices
- URL: https://www.fdaweb.com/senator-concerned-about-cybersecurity-and-chinese-devices/
- Published: 2026-05-26T12:00:00.000Z
- Updated: 2026-09-14T13:39:50.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5161203

Senator **Tom Cotton** (R-AR) is pressing FDA and government cybersecurity officials to review Chinese-made medical devices cleared before updated cybersecurity requirements took effect, citing concerns that vulnerable devices could expose Americans to espionage, fraud and potentially dangerous remote manipulation.

In a [5/26 letter](https://www.cotton.senate.gov/imo/media/doc/5%5F26%5F26%5Ffda%5Fletter%5Ffinal.pdf?ref=fdaweb.com) to acting FDA commissioner **Kyle Diamantas**, Cotton says networked medical devices manufactured in China pose risks to both national security and public health because of cybersecurity vulnerabilities that could allow unauthorized access to sensitive patient data and device controls.

The lawmaker points pecifically to concerns surrounding the Contec CMS8000 patient monitoring device, which became the subject of warnings issued jointly by FDA and the Cybersecurity and Infrastructure Security Agency (CISA) in 1/2025\. FDA later issued a Class 2 recall for the device on 5/14 of the same year, according to the letter.

According to Cotton’s letter, regulators found the China-manufactured device automatically extracted personally identifiable patient health information when connected to the internet. He warned such data breaches could expose Americans to identity theft, insurance fraud, extortion and other cybercrimes.

Cotton also cites findings from CISA that the device allegedly allowed unverified users to remotely control the monitor without healthcare providers’ knowledge, potentially enabling malicious actors to alter how the device displayed patient data.

The senator says compromised monitoring systems could contribute to dangerous medical errors involving conditions such as heart failure, arrhythmias and hypertension.

Cotton notes that while FDA began requiring enhanced cybersecurity safeguards for new medical devices seeking premarket clearance in 2023, those requirements did not apply retroactively to devices already on the market. “As a result, more must be done to protect Americans from compromised medical devices,” Cotton writes.

He urges FDA and CISA to jointly review Chinese-made medical devices that received clearance before 3/29/2023, which is when updated cybersecurity requirements took effect.