FDA Faces Staffing Challenges in Medical Device Recall Oversight

GAO Report Highlights Staffing Shortages

A recent report from the U.S. Government Accountability Office (GAO) indicates that the Food and Drug Administration (FDA) is struggling with inadequate staffing levels, which hampers its ability to effectively oversee medical device recalls. The report, covering the period from fiscal year 2020 to 2024, reveals that the FDA’s limited resources hinder its oversight activities. During this timeframe, the U.S. experienced a total of 3,934 medical device recalls. Due to these staffing constraints, the FDA was unable to meet its objective of concluding recalls within three months. The GAO stated, “FDA’s challenges — such as insufficient staffing — can create inefficiencies in the process and potentially put lives at risk.”

Historical Context and Recent Developments

This report builds on the GAO’s 2011 recommendation for the FDA to strengthen its recall oversight. Although the findings informed the Food and Drug Administration Safety and Innovation Act, experts argue that the enhancements to medical device safety were insufficient. In December 2023, Senators Richard Durbin and Richard Blumenthal urged the GAO to assess the FDA’s management of device recalls, referencing Philips’ recall of over 15 million respiratory devices that started in 2021. Notably, the timeframe discussed in the GAO report occurred prior to significant budget cuts imposed by the Department of Health and Human Services (HHS) in February and April, which affected staffing at the FDA’s device center.

Structural Changes and Hiring Challenges

The Office of Inspections and Investigations (OII), responsible for inspections and enforcement activities, underwent restructuring in 2024, consolidating all device recall coordinators into a single branch. Although the OII initiated efforts to hire additional recall staff, a hiring freeze implemented in early 2025 hindered these efforts. OII officials noted that medical device recalls outnumber recalls of biologics and drugs annually. The complexity of device recalls often involves both physical devices and associated software.

Recall Statistics for Fiscal Year 2024

According to the GAO, the FDA reported the following recall figures for fiscal year 2024:

  • 1,017 Medical device recalls
  • 333 Biologics recalls
  • 318 Drug recalls

OII officials indicated that they frequently lack adequate staffing for essential recall activities, such as reviewing manufacturer recall status reports and performing in-person audit checks. As a result, the agency prioritizes higher-risk recalls and earlier stages of the recall process, often relegating recall terminations to a lower priority due to resource limitations.

FDA’s Acknowledgment of Staffing Constraints

The GAO report highlighted that while the FDA recognizes its staffing limitations, it lacks comprehensive data on the necessary number and type of personnel required for effective oversight of device recalls. The report also referred to HHS’s prior intentions to reduce the FDA workforce, with Secretary Robert F. Kennedy Jr. announcing plans to cut approximately 10,000 positions across the department, including around 3,500 at the FDA. The GAO recommended that HHS collaborate with the FDA to improve workforce planning for device recalls, a suggestion that HHS has agreed to.

Need for Enhanced Recall Authority

The FDA may benefit from stronger authority to compel device manufacturers to follow its recall recommendations. Although the FDA has the power to mandate recalls, it seldom utilizes this authority due to the lengthy, complex procedures involved. Since acquiring this power in 1990, the FDA has mandated recalls only four times. Most device recalls are voluntary and typically arise from manufacturer-identified issues. The FDA has encountered difficulties when it disagrees with a manufacturer’s recall strategy, such as instances where the agency believed a public notification was necessary, but the manufacturer opted against it.

Legislative Efforts to Improve Recall Processes

In light of these challenges, Senator Durbin and Representative Jan Schakowsky recently introduced the Medical Device Recall Improvement Act. This legislation aims to enhance the medical device recall process by mandating the FDA to develop an electronic format for recall notifications. It would also require manufacturers to send electronic notifications to the FDA, hospitals, and healthcare providers, along with detailed information on how a recall could impact patients.