FDA announces overhaul of medical device approval system
November 28, 2018
By Neozene

The FDA plans to overhaul the decades-old medical device approval system that has been criticized by experts for risky implants and failure to catch problems, it announced Monday.

The decision comes one day after an investigation on global medical device safety was published by the International Consortium of Investigative Journalists (ICIJ) — with over 250 journalists from more than 50 organizations helping with the investigation.

The investigation found more than 1.7 million injuries and almost 83,000 deaths may have been linked to medical devices over a 10-year period in the U.S., as reported to the FDA.

FDA Commissioner Scott Gottlieb and Jeff Shuren, director of the Center for Devices and Radiological Health, announced the overhaul of the FDA 510(k) program — which approves medical devices — in a statement Monday.

“We believe that where appropriate, new medical devices that come to market under the 510(k) pathway should either account for advances in technology or demonstrate that they meet more modern safety and performance criteria. We want to make sure that new devices are evaluated against advances in technology that can improve patient safety and performance,” Gottlieb and Shuren said in the statement.

The statement acknowledged that manufacturers “generally rely on comparative testing” to decades-old products to determine if new devices are safe. Technology in older devices may not resemble modern technology in newer devices, however, and properly assess risks or benefits.

This means many medical devices must just show they are similar to existing ones on the market instead of completing individual extensive clinical trials.

The framework that is used to evaluate effectiveness and safety of medical devices in the U.S. was passed by Congress in 1976 — 42 years ago.

“Data show that nearly 20 percent of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies,” Gottlieb and Shuren said.

The FDA noted that the current guidelines may hinder the outreach of new technology to patients.

“Sometimes, by relying on old predicates, it can actually make it more difficult for more advanced technology to reach patients since it’s harder for an innovative product to bridge to an outdated technology reflected in a decades-old predicate,” FDA officials said in the statement. “Our new proposed approach enables us to help improve safety and performance, as appropriate, and ensure new products can more easily reflect beneficial new advances.” the announcement said.

The plan to the approval for medical devices may take years to implement, however. Certain new approval controls may require “intensive” work with manufactures — including new labeling or restrictions on sale of certain devices, in response to safety concerns — and may be “ineffective.” The FDA will work with congress as they determine the steps to develop new regulations.

“We recognize that our approach as regulators must continue to evolve, to anticipate and meet the challenges and opportunities of the coming decades. We must look ahead,” the announcement said.