Researchers Call On FDA to Tighten Requirements for Breakthrough Device Approvals

Researchers are pushing the FDA to beef up post-market requirements for its breakthrough devices program.

The call to tighten requirements was based on the results of a study by researchers from the University of California San Francisco School of Medicine and the Yale University School of Medicine, published in JAMA Internal Medicine, that evaluated clinical trials to assess the safety and efficacy of cardiovascular devices approved through the agency’s priority review program.

The researchers said the FDA needs to tighten post-market controls, particularly for breakthrough devices, noting it can take years to gather such data.