The 510(k) Pathway for Premarket Notification
The 510(k) pathway is a premarket approval application process authorized under section 510(k) of the FD&C Act. This type of application is required for all classes of devices that either don’t require a PMA application or are exempt from 510(k) requirements in the FD&C Act. As mentioned in my previous post, this generally covers some class I and most class II devices. In the traditional 510(k) application a sponsor presents evidence that the proposed device is “substantially equivalent” or SE to a similar legally marketed device, often referred to as the predicate device. The new device does not have to be identical to the predicate device. Rather, it must meet one of these two criteria to be SE:
- It has the same intended use and the same technological characteristics as the predicate, or
- It has the same intended use as the predicate, has different technological characteristics which do not raise different questions of safety and effectiveness, and the application demonstrates that the device is at least as safe and effective as the legally marketed device
There are two additional options for sponsors of devices that meet certain requirements. These options offer the benefit of shorter preparation time and expedited review:
- Special 510(k)s – for certain device modifications, the existing requirements of design control (including risk analysis, verification, and validation) provide assurance that the modified device will still perform as originally cleared. If a modified device requires a 510(k), the summary information may be used as the basis for clearance.
- Abbreviated 510(k)s – may be used where additional controls exist such as a guidance document, established special controls, or a consensus standard for the device type. Sponsors of devices meeting the requirements of this pathway have to option of using a 3rdparty to assess conformance with the standard and provide a statement of conformance that may be used in the Abbreviated 510(k) submission.
I’ll post more about Special and Abbreviated 510(k) applications in future posts. You may also read more details about the Traditional 510(k) pathway at this web site.
Text Copyright © 2019 Katrina Rogers