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FDA action plan to strengthen monitoring of medical devices
The FDA will focus more on the safety of devices after they become available.
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The FDA’s Postmarket Transformation Leadership Team, which formed in January 2006, developed a plan to monitor devices after they reach the market.
The team’s plan focuses on areas such as enhancing risk and benefit communication efforts and developing data systems.
The Center for Devices and Radiological Health (CDRH) completed an assessment last year and analyzed the tools used to monitor the safety of medical devices after the FDA approves them for marketing. The Postmarket Transformation Leadership Team’s (PTLT) purpose was to evaluate the CDRH’s report, “Ensuring the safety of marketed medical devices – executive synopsis and recommendations.” The PTLT was to supplement the recommendations and offer a plan for the postmarket process.
“Many of today’s medical devices are smaller and more complex than ever, offering new medical opportunities that have benefitted literally millions of people,” said Scott Gottlieb, MD, deputy commissioner for medical and scientific affairs, in a press release.
Focus on communication
The team’s report focused on four main ideas: collaborating on improved enforcement strategies and outcomes, developing better data systems, enhancing the CDRH’s culture of collaboration, and enhancing risk and benefit communication efforts. These efforts should identify and act on risks associated with medical devices approved for marketing.
The team proposed creating an organizational structure within the CDRH to integrate premarket, postmarket and enforcement efforts. Collaboration should occur as part of a routine. They also recommended developing a system to identify a device and track information associated with the device. The team also proposed developing performance measurements internally to track the handling of issues such as recalls and mandatory use of electronic reporting for adverse event reports. The Manufacturer and User Facility Device Experience Database (MAUDE) system, which records reported adverse events, should be improved.
The report also recommended that the agency increase the use of Medical Product Safety Device Network (MedSun) programs, enhance the risk and benefit communication to provide health practitioners, patients and consumers with up-to-date data and safety issues, and increase cooperation between the agency’s compliance and enforcement programs.
Among all of their recommendations, the PTLT urged the agency to immediately address the following actions:
- Develop methods for tracking postmarket issues.
- Create collaborative project groups to complement the CDRH.
- Develop unique identifiers for devices.
- Revise and update the MAUDE system.
- Require medical device reporting.
- Develop a risk communication strategy.
- Enhance MedSun programs.
- Increase interactions between the CDRH, Office of Regulatory Affairs and Office of Chief Counsel.
- Design a project to test the usefulness of decision-making methods for regulation of medical devices across the product life cycle.