September 19, 2019

FDA Releases Guidance Documents for Industry on 510(k) Programs

The U.S. Food and Drug Administration (FDA) released guidance in September 2019 regarding premarket notifications able to leverage the efficiencies of the Special 510(k) and Abbreviated 510(k) programs. The FDA also released the foundational guidance and is requesting comment on specific implementations of the new Safety and Performance Based Pathway.

Three types of premarket 510(k) notifications may be submitted to the FDA by the manufacturer/sponsor, depending on certain considerations: Traditional, Special and Abbreviated. The Special and Abbreviated 510(k) types were established in 1998 and described together in a consolidated guidance, which has been superseded by the 2019 documents.

The Special 510(k) program expedites the review of certain device modifications that would not affect the device’s intended use or change fundamental scientific technology. The current FDA thinking on the Special 510(k) paradigm, as discussed in the guidance, enables the program to be leveraged if the methods to evaluate the device modifications are “well-established” and if the results can be sufficiently reviewed in a summary or risk analysis format. The new guidance provides additional clarifications to manufacturers and reviewers regarding these considerations.

The Abbreviated 510(k) program offers manufacturers a more expedient process when the submission relies on FDA guidance documents, demonstration of compliance with special controls and/or voluntary consensus standards. The new document provides guidance on this alternative approach for demonstrating substantial equivalence to a legally marketed device.

The FDA also released the foundational Safety and Performance Based Pathway guidance. In this pathway, the submitter could demonstrate that the device meets FDA-identified performance criteria (i.e., instead of direct predicate comparison) to demonstrate that it is at least as safe and effective as the legally marketed device. The Safety and Performance Based Pathway is limited to “well understood,” FDA-specified device types and performance criteria that meet certain requirements.

For now, the agency is requesting comment on performance criteria and testing methodologies for the four initial device types under consideration for the pathway: spinal plating systems, cutaneous electrodes for recording purposes, conventional foley catheters and orthopedic non-spinal metallic bone screws and washers. The FDA intends to expand the device types eligible for this pathway over time to other well understood devices.