Recent FDA Regulations to Bring a Volume of Pipeline Products to Market

Recent changes to the U.S. Food and Drug Administration’s (FDA) 510(k) premarket clearance pathway will significantly benefit the medical device market this year.

GlobalData predicts the changes will bring a bevy of pipeline products to market, and projects sales to skyrocket by 24.7%. 
 
GlobalData’s report, “Regulations in Medical Devices – Thematic Research,” concludes 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.
 
“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,” said Joselia Carlos, a medical devices analyst at GlobalData. “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, 45 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 U.S. market without any evidence they are safe. Manufacturers must still prove their products are “substantially equivalent” to another legally marketed device the FDA has already approved or cleared. 
 
“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,” Carlos noted.