Under the New 510(k) paradigm (the guidance was published in 1998, so it’s hardly that new), there are 3 ways that sponsors may file a premarket notification for their device. Page 11 of that guidance document contains a flow chart that may help sponsors choose which way to file. The Traditional 510(k), discussed in part 2 of this series, is always available for all applications. When the new device is a certain type of modification of a previously cleared device and the design process used for the modification is appropriately controlled and documented, a sponsor may submit a Special 510(k) application instead of a Traditional 510(k). If the device modification includes a change to indication for use or alteration of the device’s fundamental scientific technology, a Special 510(k) would not be appropriate.

So what does it mean to appropriately control the design process? The specific regulations are listed in 21CFR 820.30, which require that all Class II and III devices and certain Class I devices are required to be designed in conformance with this regulation. Once that conformation has been established, certain types of changes to the device require only documentation that the design changes are evaluated using a risk management framework along with appropriate verification and validation activities to ensure the changes to the device do not change its safety or efficacy. Once this process has been completed, the documentation submitted in a Special 510(k) application is evaluated by the agency to ensure the modified device has the same benefit/risk profile as the original device. The modified device may then receive agency clearance.

An updated draft guidance on the Special 510(k) program was issued in September 2018. This draft guidance, when final, is intended to update the Special 510(k) Program to expand the types of changes eligible for the Special 510(k) Program. Specifically, the FDA proposes that a design or labeling change to an existing device (including certain changes to indications for use) may be reviewed under a Special 510(k) when:

1. The proposed change is made and submitted by the manufacturer authorized to market the existing device;
2. Performance data are unnecessary, or if performance data are necessary, well-established methods are available to evaluate the change; and
3. All performance data necessary to support substantial equivalence can be reviewed in a summary or risk analysis format.

When final, this guidance will replace the Special 510(k) policy in “The New 510(k) Paradigm – Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications,” issued on March 20, 1998. The Abbreviated 510(k) policy within the 1998 guidance document will still be in effect for Abbreviated 510(k)s, which I’ll review in my next post. The Special 510(k) pilot program was launched in October 2018 to provide an opportunity for the agency to evaluate the proposed changes with actual sponsor submissions. All Special 510(k)s submitted to CDRH on or after 01OCT2018 will be considered as part of the pilot. Interested readers are encouraged to review the slides and transcript of the pilot program webinar held last November.

Text Copyright © 2019 Katrina Rogers