Recent changes to the FDA’s 510(k) premarket clearance pathway will result in the volume of pipeline products reaching the medical devices market experiencing a compound annual growth rate (CAGR) of 24.7% by 2024, says GlobalData, a leading data and analytics company.

GlobalData’s latest report, ‘Regulations in Medical Devices – Thematic Research’, reveals that it takes approximately four to six years for devices to be approved or cleared, and even then, only a few of them make it to the market. While the recent changes will reduce the number of barriers that prevent life-saving medical technologies from entering the market, patient safety is not guaranteed.

Joselia Carlos, Medical Devices Analyst at GlobalData, comments: “Many safety problems still emerge after the approval or clearance process despite the FDA’s rigorous evaluation of the safety and efficacy of newly developed products. For instance, the FDA allows the use of the Atricure’s Lariat device for left atrial appendage closure. However, the device has not gone through the necessary testing to evaluate its safety and efficacy, specifically for left atrial appendage ligation, since receiving FDA 510(k) clearance for soft tissue ligation in 2006. In 2015, forty-five patients who received left atrial appendage closure with the Lariat device experienced severe adverse events.”

The FDA’s 510(k) premarket clearance pathway will help more life-saving medical devices break into market; however, it allows the devices to enter the US market without any evidence that they are safe. The caveat is manufacturers must still demonstrate that their products are ‘substantially equivalent’ to another legally marketed device that already has FDA approval or clearance.

Carlos concludes: “There is always an increased risk when trying out an FDA newly cleared or approved product as the regulator does not develop or test any of the products it evaluates. Rather, it makes an informed decision to clear or approve a product by outweighing the benefits with the risks based on the clinical trial results of the company that made the product.”