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FDA issues report on medical device safety initiatives

by HealthCare Business News | April 18, 2024
FDA headquarters in Silver Spring, MD
The FDA's Center for Devices and Radiological Health (CDRH) has released a new report emphasizing the agency's focus on safety in the medical device sector, outlining its strategic efforts and proposing new actions for the upcoming year.

The Safety Report serves as a follow-up to the 2018 Medical Device Safety Action Plan, outlining enhancements in device safety protocols and the management of safety signals throughout the life cycle of devices.

A key initiative highlighted in the report is the enhancement of manufacturing quality. The CDRH has expanded the Medical Device Single Audit Program (MDSAP), collaborating with the International Medical Device Regulators Forum to streamline regulatory audits globally in efforts that now include participation from over 6,946 manufacturers.

In terms of postmarket surveillance, the report highlights CDRH strides in strengthening the infrastructure to monitor devices after they reach the market. The National Evaluation System for health Technology (NEST), operated with support from the Medical Device Innovation Consortium, now includes a vast network with access to data from over 161 million records, which the FDA says supports real-world device performance and safety.

The report also emphasizes efforts to increase transparency and communication. The CDRH has enhanced the capabilities of the Manufacturer and User Facility Device Experience (MAUDE) database, making adverse event data more accessible and searchable by incorporating unique device identifiers (UDIs).

Looking ahead, the CDRH describes plans to continue advancing medical device safety through several initiatives. These include expanding participation in the Voluntary Improvement Program, enhancing the medical device recall program, and further developing tools to track and assess device quality.

The full safety report can be read here.

In addition to the safety report, the FDA simultaneously unveiled the 2024 Innovation Report, which highlights progress in bringing cutting-edge technology to the forefront. The report notes that since 2009, CDRH has expanded its clinical trial and premarket review frameworks, notably the 510(k) and De Novo pathways, and introduced programs such as the Breakthrough Devices Program. These efforts have quintupled the number of innovative medical devices authorized annually in the U.S. since 2009.

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