510(k) Process / 510(k) Clinical Testing

Much of the innovation that occurs in the medical technology realm is the result of incremental progress. Based on feedback from physicians or patients, for example, a company may decide to modify an existing product for ease of use or greater comfort. Advances in materials science or other disciplines may prompt a company to change a product to increase durability or longevity.

FDA’s regulatory approach to medical technology recognizes this and provides an efficient pathway for low- and moderate-risk devices and diagnostics to get on the market while still ensuring their safety and effectiveness. Unfortunately, this premarket notification pathway – commonly known as “510(k)” - is “perhaps the most misunderstood program in the world,” according to Dr. Susan Alpert.

Simply put, the 510(k) process requires that a new low-or moderate-risk device must prove it is at least as safe and effective as another device (or “predicate”) with the same intended use that is already on the market.

In order to prove the new device is “substantially equivalent” to a predicate, a new 510(k) submission can include hundreds, even thousands, of pages of scientific evidence based on bench testing, biocompatibility, animal studies, usability testing, and conformance with national and international standards.

Because the safety profile of the predicate device is so well-understood by FDA, the evidence requirements for a new 510(k) are not as extensive as they would be for a brand-new innovation. As Susan explains, the answers to the most important safety and effectiveness questions can be found during applicant-predicate bench testing, “by testing technologies side by side where you can actually look at the product, challenge the product, and compare performance rates.”

Still, if FDA determines clinical testing of a new 510(k) is required to supplement bench testing, the manufacturer must provide the requested data. This occurs for about 10-15 percent of 510(k) applications.

The bottom line is that the 510(k) process is not a “rubber stamp” or “loophole” as some critics claim. Susan explains, “It’s not a simple process. It contains a lot of information, it requires a lot of testing, and multiple different discipline teams at FDA review every aspect. It’s very robust.”

Learn more about the 510(k) process in the videos below, where Susan clears up the myths and misconceptions surrounding it. Learn more about Premarket Requirements.

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