The third type of premarket notification available under the New 510(k) paradigm is the Abbreviated 510(k). This notification was originally authorized for use on a modified device when there exists an issued guidance, an established special control (for example, performance standards, postmarket surveillance, or patient registries), or a consensus standard to which the sponsor can demonstrate documented conformance. The Abbreviated 510(k) submission should include a summary report that describes how the modified device adheres to the guidance/control/standard and how it was used during development and testing of the device. 

Under the optional 510(k) Safety and Performance based pathway guidance, sponsors of new medical devices could satisfy the legal requirement to demonstrate SE with a predicate device by demonstrating that the new device meets performance criteria established in guidance, special control, or consensus standard. In order to be eligible, the new device must:

• Have indications for use and technological characteristics that do not raise additional questions of safety and efficacy than the predicate device,
• Have performance criteria that align with the performance of one or more legally marketed predicate devices, and
• Meet all the established performance criteria.

The purpose of the Safety and Performance Based pathway is to provide developers of new devices with a less burdensome method of demonstrating SE than performing direct comparision studies against the predicate device (the method used for Traditional 510(k)s). Interested readers may learn more about the new pathway from its website. I have a previous post on the use of consensus standards to meet submission requirements, and I’ll describe the standards and conformity assessment program in a future post. In the next post I’ll discuss a method for sponsors to accelerate their premarket applications by using a 3rd party to assist with device review.

Text Copyright © 2019 Katrina Rogers