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# Sen. Scott Security Concerns Over Chinese Medical Devices
- URL: https://www.fdaweb.com/sen-scott-security-concerns-over-chinese-medical-devices/
- Published: 2026-10-05T18:03:36.000Z
- Updated: 2026-10-05T18:03:36.000Z
- Author: David McFarland
- Tags: Devices

Senate Aging Committee chairman **Rick Scott** (R-FL) is raising concerns about Chinese medical device manufacturers seeking to enter the U.S. market, warning that devices capable of collecting patient information could pose cybersecurity and health-data risks.

In a [10/2 letter](https://www.rickscott.senate.gov/services/files/79777DE8-6B14-4524-A8E8-3E5AFB6F7769?ref=fdaweb.com) to CMS administrator **Mehmet Oz**, Scott specifically points to Chinese manufacturers of continuous glucose monitors (CGMs) that are already selling products in Europe and “desire to enter the U.S. market.” While the letter does not specifically ask FDA to take action, CGMs generally require FDA authorization before U.S. marketing, potentially putting the agency's medical-device review and cybersecurity requirements at the center of any efforts by those manufacturers to enter the U.S. market.

Scott cites Contec Medical Systems as an example of his broader concern. The Cybersecurity and Infrastructure Security Agency previously warned that a Contec patient monitor contained an “embedded backdoor function” involving a hard-coded IP address and functionality that could enable patient data leakage.

Scott argues that Chinese companies should not be allowed to gain access to patient information through federal health programs and is urging CMS to favor U.S.-made medical devices and pharmaceuticals. He also wants CMS to require medical-device and service providers to store data domestically and says federal funds should not be used to purchase Chinese-manufactured medical equipment when a domestic alternative is available.

The senator specifically raises concerns about the $50 billion Rural Health Transformation Fund, saying Chinese manufacturers should not be allowed to use the program as an avenue for expanding sales of medical devices to rural healthcare providers.

Scott's letter follows a Senate Special Committee on Aging hearing examining China's role in the U.S. healthcare system and potential risks involving health and genetic data.