How the New 510(k) Ruling is Affecting Manufacturers

According to RAPS, the new 510(k) ruling by FDA details “how regulators will evaluate applications in order to determine ‘substantial equivalence.'” In the past, medical device manufacturers were able to reference separate but similar devices or products (called predicate devices) that had already been marketed in order to assess the safety of their new device.

This process is called demonstrating substantial equivalence, and the new ruling has made changes to the way certain predicate devices are able to be determined and how the new product can be compared to them. This means changes for your medical device manufacturing company and your process of demonstrating substantial equivalence.

The New Ruling and Its Changes

The new ruling has created new challenges for manufacturers who were previously able to determine substantial equivalence by using separate predicate devices that have different intended uses from the new product. This ruling was made for many reasons, including:

  • “The failure to fully appreciate the difference of new device iterations cleared through the 510(k) process” can be extremely dangerous for patients and needed to be reevaluated.
  • The previous process had given manufacturers more ability to rely on the predicate device’s safety record than on the evidence of the new device’s safety.
  • FDA received extensive calls to make changes to their 510(k) process in 2011 after releasing a largely unchanged new 510(k) guidance document titled 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device.

For medical device manufacturers, the 510(k) ruling does create the need for many changes, but it need not be impossible or difficult to adjust to them. There are also many tips that manufacturers can use in the wake of these changes to create safe, efficient products that can meet the standards of the new 510(k) ruling.

Multiple Predicate Devices

Although the split predicate concept is no longer acceptable under the 510(k) regulatory program, manufacturers can use multiple predicate devices in order to determine substantial equivalence. This is possible under certain circumstances, as when a company wishes to show that FDA “had found similar technology or indications to be substantially equivalent.”

This does not mean that multiple predicate devices will necessarily determine substantial equivalence but that it will help prove the legitimacy of the application and the product itself.

Reference Devices

Reference devices are another possibility and can be used “to support scientific methodology or standard reference values.” Reference devices are like predicate devices except that they will be better used in comparing technologies that are used in the device rather than the two devices themselves. These can also add to the legitimacy of the 510(k) application.

What Is FDA Looking For?

According to FDA, “It follows that the evidence necessary to show substantial equivalence will increase as differences between the new device and the predicate device increase if those differences significantly affect, or may significantly affect, safety or effectiveness.” When you are determining your substantial equivalence between the new product and the predicate device, you want to make the comparison as smooth as possible. This means the devices must have:

  • “The same technological characteristics”
  • A change in the devices does not cause safety questions and other concerns about the device
  • Equal or better effectiveness from the new device

FDA wants to see a legitimate comparison between the new device and the predicate device. The new ruling will cause changes in how you are able to do this, but its highest requirement is creating a safe and effective product for the patient.