FDA Announces First Steps in Medical Device Approval Overhaul

Breast Implants

On November 20, 2018, the U.S. Food and Drug Administration (FDA) released a statement outlining the steps it is taking to overhaul its existing medical device approval process. The agency’s first goal is to enhance post-market safety by investing in new tools and developing new policies to identify and act upon safety signals related to existing medical devices.

The current post-market surveillance program depends on users to report problems. The new strategy is to use the FDA’s unique device identification (UDI) system to generate, access and evaluate large data sets on device performance and clinical outcomes associated with device’s use in routine clinical practice.

The FDA is also committing new resources to its new national system for gathering real world evidence (NEST), which will allow both the agency and device manufacturers to receive clinical evidence more quickly. “NEST leverages a wide range of data systems that could provide crucial information on medical devices, including data from patient registries, Medicare claims and electronic medical records. Moreover, it was designed from the very beginning to serve as a resource for the entire community, which is why the Governing Board for NEST’s independently run public-private coordinating center (called NESTcc) is comprised of members representing the key community stakeholders, including patients and providers,” according to the press announcement. Funding for the program comes from both the FDA and industry.

One of the initial areas of focus for the new systems will be Women’s Health, including breast implants, “vaginal rejuvenation” devices and gynecological surgical mesh.

The full statement is available here.

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