A new medical device is automatically classified as a Class III device and must undergo premarket approval unless the manufacturer can demonstrate to FDA that the device is substantially equivalent to a predicate device.
In order to establish substantial equivalence, the manufacturer must submit premarket notification through a 510(k) submission to FDA. If FDA rules that the device is substantially equivalent to the predicate device, it will receive the same designation of risk classification, Class I, II, or III, as its predicate device. If FDA determines the device is not substantially equivalent, it will be classified as Class III and require premarket approval for marketing and reclassification if deemed appropriate.
When a manufacturer pursues market approval for a new device, FDA wants to reduce the burden for their reviewers while still documenting safety and efficacy. The Medical Device Amendments (MDA) to the Federal Food, Drug, and Cosmetic Act were enacted on May 28, 1976 for this purpose. It allows manufacturers to demonstrate that their new device is substantially equivalent to a device already approved to be legally marketed in the U.S. – a predicate device.
To establish substantial equivalence, the manufacturer must be able to present a strong case proving the device has a similar purpose and is at least as safe and effective as the predicate device. There are two categories of predicate device:
A manufacturer may not choose a predicate device in violation of the FD&C Act, but it does not have to be currently sold and distributed on the market.
FDA recommends that you choose a predicate device that is most similar to your device with regard to indications for use and technological characteristics. Similarities in the following characteristics help build the case for proving a device is substantially equivalent to a predicate device:
In addition to these criteria, choosing a more recently approved predicate device is preferred due to the rapid changes in technology since 1976. In fact, FDA is considering updating its rules to require that predicate devices be less than ten years old.
The FDA 510(k) database lists all devices cleared through the process, and it is a good starting point in the search for choosing the right predicate device to use. Additional reference devices may be included in the 510(k) submission to support scientific methodology or standard reference values.
A 510(k) submission is a complex process that requires a great deal of organization and attention to detail. The FDA Refuse to Accept Policy outlines the minimum threshold of acceptability for these submissions, but even with this guidance 70 to 75 percent of 510(k) submissions are rejected the first time.
Greenlight Guru’s medical device QMS software includes a built-in advanced document management workflow to create submissions and streamline approvals by maintaining accurate and accessible records for the necessary team members. Using this purpose-built solution makes establishing substantial equivalence to a predicate device easier, getting your product to the patients who need it faster.