Devices

GAO Sees Actions, Challenges in Device Surveillance

The Government Accountability Office (GAO) says FDA has faced challenges in its efforts to establish an active postmarket surveillance system for medical devices. The report identifies these steps that the agency has taken:

establishment in 2016 of a coordinating center to partner with FDA to organize a network of data sources (health systems and other collaborators);
completing in 2021 the cloud-based data infrastructure needed to collect evidence of medical device performance while protecting patient privacy; and
planning to begin active postmarket surveillance of medical devices by December, with plans to expand over five years.

GAO says FDA has faced two key challenges in establishing its system:

limited use of unique device identifiers in electronic health records and billing claims, making identifying devices used by patients more difficult; and
funding considerations to support active surveillance.

“FDA has taken actions to encourage use of device identifiers,” the report says, “such as coordinating with federal entities and publishing a document advertising the benefits of use to health systems. In addition, FDA has estimated current and future active surveillance costs and is considering options for how to fund the work by advocating for alternative funding sources.”

GAO says it will continue to monitor the agency’s progress in establishing an active postmarket surveillance system.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome