Five years after promising to fix a flawed regulatory pathway widely used by medical device manufacturers, the Food and Drug Administration has issued new guidelines to improve its so-called 510(k) program that has long been lambasted for letting risky devices fall through the cracks.
Most medical device companies do not have to test their products on people in order to secure clearance from the FDA — they simply have to show they’re “substantially equivalent” to devices already on the market, called “predicates.” This process is the 510(k) pathway, and accounts for the vast majority of new medical devices launched on the market each year. Devices cleared through this pathway include X-ray machines, muscle stimulators, and wheelchairs.
Last week, the FDA released a trio of guidelines clarifying the way it plans to evaluate devices that go through the 510(k) pathway. The agency is asking manufacturers to avoid predicate devices that were recalled due to a “design-related” issue or have “unmitigated” safety concerns. Manufacturers should submit flow charts explaining why they chose their predicate device. If they have to choose one with a recall history or safety issues, they should explain how the new device addresses those problems. The FDA may also ask the manufacturer for clinical data in this case.