On Monday, November 26, the U.S. Food and Drug Administration (FDA) stated it will be updating the review process for most medical devices before they are cleared for marketing. The FDA is implementing the update to encourage manufacturers to rely less on their older devices in showing that their new products are safe and effective.
What Caused the Update and What Happens Next?
In an effort to keep up with the rapid evolution of health technology, FDA Commissioner Scott Gottlieb stated that the agency would be updating its 510(k) clearance pathway put in place since 1976, a process that currently relies on comparisons to older devices already on the market, known as predicate devices. The FDA wants companies to focus on using predicate devices that are less than 10 years old. Gottlieb stated that almost 20 percent of medical devices are cleared based on predicate devices over 10 years old.
Nevertheless, Gottlieb clarified that the push for a modernized review process doesn’t mean the older devices need to be pulled from the shelves. He also clarified that the comparisons to older models “doesn’t mean the [current] products are unsafe.” “It does mean that some devices may not be continually improving, which is the hallmark of health technologies,” said Gottlieb. The FDA chief also stated how the agency intends to finalize updates to the review process in early 2019, establishing an alternative 510(k) pathway which also allows makers of familiar types of medical devices to use objective safety and performance criteria to show that their devices are substantially equivalent to products already on the market.
The FDA believes that the use of more recent predicates by manufacturers would give doctors and their patients more options to choose between newer and older devices, encourage the adoption of more modern safety and performance features, and ensure that newer devices use more modern technology and standards. Gottlieb also stated that public feedback on the updated review process will be requested in an effort to take other criteria into account and to further promote the use of newer devices.
Medical devices reviewed through the 510(k) clearance pathway have become more complex and often have different technological features from the predicate devices they’re based on. Gottlieb stated, “Newer devices are more often interconnected and interoperable, increasing cybersecurity threats,” Therefore, no new medical device is exactly the same as its predecessor. The FDA classifies medical devices according to the risk posed by a device. Medical devices are able to change classification systems depending on the results of scientific data. For more information on the class types of various medical devices and their requirements, visit this page.
Scott Whitaker, president of the Advanced Medical Technology Association, said that the trade group will work with the FDA on updating the current review process, but hopes the agency will realize that sometimes, there are legitimate reasons for using older predicates. “The proposed 10-year cutoff criteria could prove arbitrary as older predicates can offer extensive data about their performance, helping sponsors introduce newer, safer devices,” said Whitaker.