FDA report details flaws in med tech surveillance

One of the factors which has given med tech an edge over pharma and biotech in recent years has been a comparative lack of regulation. That may be changing. The FDA this week released an internal report that concedes the agency could be doing more to regulate medical devices.

According to researchers, the Center for Medical Devices and Radiological Health, the agency body responsible for tracking potential problems, often does not have access to the data it needs to evaluate products after they reach the market. The information collected is usually not complete, the report adds, making it almost impossible for the agency to determine how serious a problem is and evaluate appropriate steps needed to address it. The FDA notes it is working toward an electronic system for monitoring and collecting data on errors and considering other changes designed to improve post-marketing surveillance.

- see this report from the FDA (pdf)

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