The US Food and Drug Administration (FDA) has updated three guidance documents on preparation and formatting of Traditional, Abbreviated and Special premarket notifications (510(k)s).
The documents are:
The guidance for Traditional and Abbreviated 510(k) formatting does not appear to change the 2005 guidance significantly with regard to the number and titles of the recommended chapters in a 510(k), but the references to other guidance documents and agency policies have been brought up to date.
Similarly, the guidance for Abbreviated 510(k)s does not differ significantly from the prior 1998 guidance with regard to the nature and content of such a submission, but again, the references to other FDA documents have been updated.
The Special 510(k) guidance updates the Special 510(k) content in “The New 510(k) Paradigm – Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications,” issued on 20 March 1998.
The guidance provides the agency’s current thinking on 510(k)s appropriate for review as Special 510(k)s. The intent of the guidance is to describe an optional pathway for certain well-defined device changes where a manufacturer modifies its own legally marketed device, and design control procedures produce reliable results that can form the basis for substantial equivalence, alongside other 510(k) content requirements.
The guidance clarifies the types of technological changes appropriate for review as Special 510(k)s. Specifically, within the revised scope of appropriate changes, FDA is including certain design and labeling changes, including changes to the indications for use.
In this respect, the Special 510(k) program was previously limited to the review of changes that did not affect the device’s intended use nor alter its fundamental scientific technology. Under this previous approach, Special 510(k)s that included modifications to the device indications for use, or any labeling change that affected its intended use, and/or modifications that had the potential to alter the fundamental scientific technology of the device compared to the previous design, were routinely converted to Traditional 510(k)s.
FDA now no longer intends to focus on changes that affect indications for use or alter fundamental scientific technology in determining whether the 510(k) is appropriate as a Special 510(k). Instead, FDA’s approach focuses on whether the method(s) to evaluate the change(s) are well-established, and whether the results can be sufficiently reviewed in a summary or risk analysis format. A Special 510(k) would generally not be appropriate for devices that manufacture a biological product at the point of care, because there would likely be no well-established method to evaluate such changes and/or the performance data would not be reviewable in a summary or risk-analysis format.