Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Qualtech Consulting Corporation
Taiwan, China, Japan, Singapore, Hong Kong, Malaysia, Philippines, Vietnam, Australia, Germany, Korea, Thailand, USA
A specialized medical device consulting firm offering a one-stop solution for complex global regulatory challenges. We offer real-time regulatory and clinical support, local representation, and QMS services across 13 markets, ensuring efficient market entry and compliance.
Registrar Corp
Hampton, Virginia (HQ), Shenzhen, China, London, United Kingdom, Paris, France, Madrid, Spain, Hyderabad, India, Kuala Lumpur, Malaysia, Tel Aviv, Israel, Guatemala City, Guatemala, Cape Town, South Africa
A global FDA compliance firm assisting businesses in the food, medical device, drug, and cosmetic industries with registration, U.S. Agent services, labeling, and regulatory software solutions.
MedEnvoy Global
The Hague, Netherlands, London, United Kingdom, United States, Switzerland, Australia
A global regulatory compliance partner specializing in in-country representation (EC Rep, UKRP, CH Rep, US Agent) and independent importer services for medical device and IVD manufacturers. We help companies navigate complex regulations in Europe, the UK, Switzerland, and the US while maintaining supply chain flexibility.
ARQon Pte. Ltd.
Singapore (HQ), Malaysia, Vietnam, Indonesia, Philippines, Thailand, Taiwan, Hong Kong, South Korea, Switzerland, USA, Australia, New Zealand, Rwanda, India, Sri Lanka
We are a premier regulatory consultancy firm specializing in medical devices, in-vitro diagnostics (IVD), and pharmaceuticals. Founded in 2014, the company offers a comprehensive suite of services ranging from product development strategy and clinical trials to product registration and post-market surveillance. With a team of experts possessing vast experience in regulatory authorities and industry, we bridge the gap between scientific innovation and regulatory compliance, ensuring patient safety while fostering medical advancement. The company also provides unique business matching services through its ATTOPOLIS platform and training through the International Medical Device School.
December 16, 2025
Approximately 5 minutes
FDA Recall Bottlenecks: GAO Report Highlights Staffing Gaps and Oversight Delays
FDA Recall Bottlenecks: GAO Report Highlights Staffing Gaps and Oversight Delays
A recent report from the US Government Accountability Office (GAO) has sounded the alarm on the FDA's ability to oversee medical device recalls. Staffing shortages and a growing volume of complex products, including AI-enabled software, have pushed critical safety work to the "back burner."
Key Findings from the GAO Report
The investigation identifies several systemic issues that could leave patient safety gaps unresolved for months:
1. Severe Delays in Recall Terminations
While the FDA's internal policy targets 90 business days to formally close a recall once a fix is completed, the current average has ballooned to approximately 260 days. Between 2020 and 2024, 62% of recalls remained listed as "ongoing," creating significant confusion for clinicians and patients regarding which devices are safe to use.
2. Resource Shifting to High-Risk Cases
Due to limited personnel, the FDA often shifts staff to focus exclusively on Class I recalls—those with the highest risk of serious injury or death. As a consequence, oversight for lower-risk recalls and essential close-out administrative steps are frequently delayed or skipped entirely.
3. Complexity of Medtech vs. Pharma
The medical device market is significantly more difficult to monitor than the pharmaceutical sector. With nearly 200,000 devices on the market, device recalls are both more frequent and technically complex. The FDA oversees approximately 1,000 device recalls per year, compared to roughly 300 in the pharmaceutical industry.
4. Reliance on Voluntary Actions
Despite having the legal power to mandate recalls, the FDA has only used this authority four times since the early 1990s. Currently, 96% of all recalls are initiated voluntarily by manufacturers.
The Impact of a Hiring Freeze
The FDA's attempt to bolster its workforce in late 2024 was thwarted by a federal hiring freeze. Previous workforce plans are now considered obsolete, leaving the agency with a team that lacks the modern skills required to manage digital and iterative device innovations.
Strategic Recommendations
The GAO has urged the FDA and the Department of Health and Human Services (HHS) to implement structural fixes, including:
- Strategic Workforce Planning: Assessing the specific skills needed for modern medtech oversight.
- Legal Authority: Considering stronger legal mechanisms to compel manufacturer actions during voluntary recalls.
- Modernized Closure Mechanisms: Streamlining the process to ensure recalls are terminated promptly once the risk is mitigated.
As medical devices become increasingly driven by software and AI, the GAO emphasizes that oversight capacity must accelerate to keep pace with innovation. Transparency alone is insufficient; effective execution is required to maintain public trust in device safety.