Demonstrating Substantial Equivalence through Performance Criteria

Melvin G. Fletcher III

By Melvin G. Fletcher III

ISO 13485, CMDR, and MDD/CE Marking Certified Lead Auditor

On April 11, 2018, the Food and Drug Administration (FDA) issued a draft guidance to describe an optional pathway for certain widely understood device types, in which a submitter would have to demonstrate that a new device is as safe and effective as a legally marketed device, and, therefore, meets FDA-identified performance criteria.  

The FDA believes that the use of performance criteria is only appropriate when the FDA has determined that all of the following are met:

  1. The new device has indications for use and technological characteristics that do not raise different questions of safety and effectiveness than the identified predicate device.
  2. The performance criteria are in alignment with the performance criteria of one or more legally marketed devices of the same type as the new device.
  3. The new device meets the performance criteria of one or more legally marketed devices of the same type as the new device.

All performance criteria for use of the Expanded Abbreviated 510(k) program will be publicized through the FDA guidance developed for purposes of this program, which may reference FDA-recognized consensus standards and special controls.

If a device cannot rely entirely on the performance criteria identified by the FDA to demonstrate substantial equivalence for its submission, then it is not appropriate for this program. However, the FDA does emphasize that the previously established 510(k) programs, in which direct performance comparisons against appropriate predicates are conducted - including Traditional, Special, and (non-expanded) Abbreviated 510(k)s - will remain available to submitters.

This new draft guidance includes the following information that the FDA plans to provide:

  • Devices appropriate for the Expanded Abbreviated 510(k) program including information about the types of devices to which the performance criteria would apply, such as the intended use and technological characteristics.
  • Identification of performance criteria for each device type, as well as the testing methods recommended in the guidance, where feasible, and any other relevant information.
  • The FDA’s review of the data that is submitted, which includes a declaration of conformity, a summary of the data, and/or underlying data, as appropriate.
  • The FDA’s intention to modify the list of pertinent device types with additional device types,  corresponding performance criteria, and testing methodology in the guidance and on the FDA website over time, as appropriate and in accordance with the FDA’s Good Guidance Practices (21 CFR 10.115).
  • An appendix that includes the submission recommendations for an Expanded Abbreviated 510(k).

The FDA’s draft guidance documents, including the one mentioned in this blog, do not establish legally enforceable responsibilities. Instead, guidance documents describe the FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word “should,” in FDA guidance documents, means that something is suggested or recommended, but not required.

If you need any assistance with implementing or interpreting the draft guidance on the “Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence Through Performance Criteria,” contact ICON at for more information. Our medical device experts have direct experience in the application of the recommendations contained within this guidance.