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Title: FDA Brings Back Medical Device Oversight Staff Due to Health and Cybersecurity Worries

FDA Brings Back Medical Device Oversight Staff Due to Health and Cybersecurity Worries

02/28/2025
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FDA Brings Back Medical Device Oversight Staff Due to Health and Cybersecurity Worries

by Raxer X.
02/28/2025
in Cybersecurity in Trade, Security & Risk

The U.S. Food and Drug Administration (FDA) has decided to bring back staff who are important for monitoring medical devices, reversing recent job cuts that had raised alarms. These layoffs, which were ordered by the Department of Government Efficiency (DOGE), caused significant concern among health advocates, industry leaders, and cybersecurity experts regarding possible dangers to public health.

Around 900 FDA employees were let go initially, sparking worries that the FDA might struggle to properly manage the approval, testing, and recall of medical devices. Georges Benjamin, M.D., Executive Director of the American Public Health Association, called the terminations reckless, warning they could risk community health across the country.

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Facing growing pressure, the Department of Health and Human Services (HHS), which oversees the FDA, informed many affected employees that they could return to their jobs. However, HHS has not shared how many employees have been reinstated and hasn’t responded to further questions.

The healthcare group AdvaMed quickly raised concerns about the layoffs. Scott Whitaker, President and CEO of AdvaMed, cautioned that cutting FDA staff could harm patient care by delaying the already slow process of reviewing medical devices. He pointed out that losing some of the agency’s top personnel could make it harder for the FDA to handle the many medical technology applications it receives.

Lawmakers also expressed their disapproval. Senate Democrats sent a letter to HHS criticizing the mass layoffs, arguing that they undermine the FDA’s work and show a lack of regard for American health and safety. They noted that the job cuts could destabilize the medical supply chain and create cybersecurity issues, posing serious risks to patients’ access to crucial healthcare services and medications.

While the FDA hasn’t provided official numbers, reports suggest about 700 employees were let go, including 220 involved in ensuring medical device safety. It appears that 180 of those dismissed were from the FDA’s Center for Devices and Radiological Health (CDRH), which includes doctors and cybersecurity specialists. This center is responsible for ensuring that medical devices are safe and meet regulations. Recently, the FDA had warned about internet-connected patient monitors that had security issues, making them vulnerable to unauthorized access.

The employees who have been brought back include those who review medical devices and specialists in food safety. Reports indicate that among the rehired are experts in cardiovascular devices and those overseeing the use of artificial intelligence in medical applications. Scott Whitaker from AdvaMed noted that a large number of expert reviewers are returning to the FDA, including many funded by industry fees from drug and device makers, which are important for the FDA’s budget.

Despite the FDA’s rehires, other federal agencies affected by DOGE’s layoffs haven’t seen similar reversals. While some staff at the National Nuclear Security Administration, U.S. Department of Agriculture, and Indian Health Service have been brought back, agencies focused on significant cybersecurity responsibilities, like the Cybersecurity and Infrastructure Security Agency (CISA), Department of Veterans Affairs (VA), and U.S. Digital Service, have not had their job cuts undone. This situation has raised concerns among experts about the potential long-term effects on national cybersecurity and public health systems.

The FDA’s choice to reinstate key staff highlights how vital it is to keep strong oversight in medical device safety and cybersecurity, especially as healthcare technologies become more interconnected and at risk of cyber threats.

Stay informed on supply chain news at The Supply Chain Report. Free international trade tools are at ADAMftd.com.

#FDA #MedicalDevices #HealthcareSafety #CyberSecurity #PublicHealth #HealthTech #DeviceRegulation #HHS #AdvaMed #TechSecurity #PatientSafety #FDARehires #MedicalTech #HealthPolicy #RegulatoryAffairs

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