Major Changes Coming To Controversial 510(K) Medical Device Approval Process, FDA Officials Say

Federal regulators say they are preparing to make significant changes to a controversial program that allows medical device manufacturers to introduce new devices with limited testing, as long as they claim the device is “substantially equivalent” to a product already on the market. 

FDA Commissioner Scott Gottlieb and Jeff Shuren, Director of the FDA’s Center for Devices and Radiological Health, issued a statement last week, announcing changes to the agency’s 510(k) program.

Most medical devices introduced in recent years were fast-tracked through the FDA’s 510(k) approval process, which allows devices deemed “substantially equivalent” to existing medical devices to be sold with little to no clinical testing. The agency has received sharp criticism for expanding the definition of “substantially equivalent,” even when manufacturers market the new devices as innovative or breakthrough technologies, which may be radically different from their predecessors.

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Gottlieb and Shuren’s announcement indicates that the changes would require devices seeking 510(k) approval factor in changes in technology from previous designs.

“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,” the officials state. “We want to make sure that new devices are evaluated against advances in technology that can improve patient safety and performance.”

The FDA officials report that nearly 20% of devices approved through the 510(k) program are based on devices that are more than 10 years old. The changes would include a push to compare new devices to more recent, comparable technology.

However, the statement repeatedly states that the agency is seeking to “encourage” product developers to link their devices to more recent technology, it never states that the agency is going to require any actual changes, saying that they are seeking a “market-based approach” to solving 510(k) issues.

The statement indicates the FDA is considering “sunsetting” some older devices, making them ineligible to be used as predicates for new technology.

The agency expects to issue new guidance for the program in early 2019, and will take public comment on that guidance from the public.

Many critics say that since the program’s inception in the 1980s, the term “substantially equivalent” has become nearly meaningless.

At the same time, concerns have emerged about problems with several devices implanted into the human body, such as metal-on-metal hip replacements and   transvaginal surgical mesh, many of which were introduced under the “substantial equivalent” test, with little pre-market testing to ensure they were safe. These same manufacturers engaged in marketing for their products that extolled the virtues of the devices, claiming that they involved “revolutionary” designs and provide vast improvements over older devices.

Originally designed for non-critical medical devices, such as band-aids and tongue suppressors, the “substantially equivalent” program has expanded over the years to include numerous medical implants, including surgical mesh, artificial joint implants, defibrillators, stents and other critical devices that are permanently implanted into the human body.

The program has come under increasing fire over the last several years, due to the number of recalls involving 510(k) approved devices, which were only found to carry unacceptable risks after they had already been implanted in thousands of patients.


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