Draft Guidance for Industry, Food and Drug Administration
Document issued on April 12, 2018.
This guidance provides FDA’s current thinking on expanding the use of the Abbreviated 510k program for demonstrating substantial equivalence for premarket notification (510(k)) submissions. The intent of the guidance is to describe an optional pathway for certain, well-understood device types, where a submitter would demonstrate that a new device meets FDA-identified performance criteria to demonstrate that the device is as safe and effective as a legally marketed device.
Through guidance, FDA has explained and clarified how it makes substantial equivalence decisions. As described in that guidance, the 510(k) program has undergone a number of statutory changes since its inception, and #FDA has adapted its implementation of the program in response to changing statutory requirements and the evolving medical device landscape. For example, FDA established alternative programs for demonstrating substantial equivalence, the Special 510(k) and the Abbreviated 510(k). The Abbreviated 510(k) submission program relies on the use of guidance documents, special controls, and FDA-recognized consensus standards to facilitate 510(k) review. The current 510(k) program reflects the current statutory framework and FDA’s implementation of that framework through regulation, guidance, and administrative practice.
Devices Appropriate for the Expanded Abbreviated 510(k) program: Intended use and technological characteristics
FDA plans to provide information about the types of devices to which the performance criteria would apply in the guidance establishing the performance criteria. Such information may include the relevant product code, appropriate intended uses, appropriate indications for use, and expectations for technological characteristics. In addition, in individual submissions for the Expanded Abbreviated 510(k) program, FDA will continue to require the identification of predicate device(s) for the intended use and technological characteristics prongs of the substantial equivalence analysis. Clarifying the set of devices for which the performance criteria are appropriate in guidance and having submitters identify a predicate of the same device type will help ensure that a new device that utilizes this program has (1) the same intended use as, and (2) technological characteristics that do not raise different questions of safety and effectiveness from the predicate device.
