The FDA routinely authorizes new medical devices that are similar to previously approved products without requiring clinical testing. This practice, known as the 501(k) pathway and authorized by a legal loophole in the approval process, puts unsafe medical devices on the market, according to a Jan. 19 New Haven, Conn.-based Yale University study.
The study, published Jan. 10 in JAMA, found 1 in 4 "loophole" approvals has been based on medical devices that later were recalled. These include Class I recalls where the FDA concluded using the device could cause harm or death.
Moreover, the newly authorized medical devices were then used to support approval for the next generation of similar devices — which also were later recalled.
Researchers reviewed the regulatory history of all medical devices subjected to Class I recalls between 2018 and 2021 and found "safety issues were pervasive."
Harlan Krumholz, MD, director of the Yale Center for Outcomes Research and Evaluation at Yale School of Medicine, said loophole is a legal issue, "not an FDA issue."
Closing the loophole would require action by Congress.