Faulty Medical Devices Prompt FDA Approval-Process Overhaul

November 26, 2018, 6:41 PM UTC

Food and Drug Administration officials on Monday said the agency would overhaul a decades-old system used by medical device manufacturers to get their products on the market, the Associated Press reported. The system is being revamped after failing to detect problems in certain medical devices, which have caused injuries to consumers in some cases.

The overhaul will base approvals of new medical technologies on clinical testing, rather than a system based on a device’s similarities to older technologies.

Over the weekend, the Associated Press published an investigation into the FDA’s expedited review process on new products, which may have led to faulty devices putting consumer safety at risk.

The FDA responded to the matter last week, saying it would need to create “a more robust medical device safety net for patients through better data.” The agency added, “Unfortunately, the FDA cannot always know the full extent of the benefits and risks of a device before it reaches the market.”

The FDA’s overhaul of the 510(k) system is meant to prompt manufacturers to base new products on technologies that are 10 years old or less, according to CNBC. Almost 20% of the products currently cleared by the system were based on devices older than 10 years. For consumer safety, the FDA is considering whether to publicize manufacturers and their devices that are based on older products.

According to the AP’s investigation, faulty spinal-cord stimulators have accounted for more than 80,000 injuries since 2008, and metal-hip replacements and insulin pumps had even more injury reports.

“What we want to do is constantly push the market toward incorporating better technology and better capabilities,” said FDA Commissioner Scott Gottlieb, a President Trump appointee, in an interview with CNBC. He emphasized the need for “constantly incorporating newer and better technology to make the devices better and safer.”