September 15, 2023

Modernizing the FDA’s 510(k) Program for Medical Devices: Selection of Predicate Devices and Use of Clinical Data in 510(k) Submissions

On September 6, 2023, the US Food and Drug Administration (FDA) released a trio of draft guidances in its efforts to “strengthen and modernize” the 510(k) Program and provide for more “predictability, consistency, and transparency” for the 510(k) premarket review process. In this post, we discuss the two new draft guidances with broad applicability to the 510(k) Program1:

Under the Federal Food, Drug, and Cosmetic Act, a submitter must demonstrate in its premarket notification submission (commonly referred to as a “510(k)”) that its device to be marketed is substantially equivalent to a predicate device. To establish substantial equivalence, the FDA must find that (i) the submitted device and predicate device have the same intended use and (ii) that the submitted device and predicate device have the same technological characteristics, or if they do not, that the differences in technological characteristics of the submitted device do not raise different questions of safety and effectiveness than the predicate device and that the submitted device is as safe and effective as the predicate device.

The two draft guidances are generally additive to existing policies — including a July 2014 FDA guidance, “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k]” (the “510(k) Program guidance”) — and address a number of fundamental issues of concern with the 510(k) process.

In this post, we highlight some key takeaways from the two draft guidances.

Best Practices for Selecting a Predicate Device

Following review of public comments received from its 2019 public notice, the FDA determined that a “best practices” focus when selecting predicate devices would be a more appropriate method to modernize the 510(k) Program with regards to the use of predicate devices, as opposed to focusing on the age of the predicate device on the market.

The Predicate Device guidance explains that a submitter should first consider the list of legally marketed devices to identify “valid predicate devices.” The Predicate Device guidance then sets forth four best practices that the FDA recommends using to narrow the list of valid predicate devices to select a predicate device:2

Modernizing FDAs Infographic

The Predicate Device guidance concludes with recommendations on how to use the four best practices and with a few examples that all use a new chart to summarize assessments involving the best practices.

Finally — and notably — the FDA recommends that submitters include within their 510(k) Summaries a narrative explaining their selection of the predicate device and how the submitter utilized the best practices in reaching its decision to use such predicate device.

Recommendations for the Use of Clinical Data in 510(k) Submissions

The Clinical Data guidance provides recommendations for when clinical data may be required to demonstrate that a submitted device is substantially equivalent to a predicate device.

The Clinical Data guidance is consistent with and expands upon the relatively brief discussion of this fundamental topic in the FDA’s 510(k) Program guidance. As explained in both guidances, when nonclinical data is insufficient or when the available scientific methods are not acceptable, the FDA may request a submitter to provide clinical performance data to support a determination of substantial equivalence.

The Clinical Data guidance expands upon the discussion of three common scenarios in which clinical data might be required and introduces a fourth scenario:



Illustrative Example

Scenario 1: Differences in the indications for use

  • Difference in patient population
  • Differences in disease
  • Differences in anatomical site, structure, or pathology
  • General to specific considerations
  • Expansion of new device’s currently cleared indications for use
  • Unknown or different benefit-risk profile for the proposed indications for use

A predicate laser device could be indicated for use as a treatment of a certain skin condition, but the new laser device is indicated for treatment of a different skin condition and uses a lower-energy wavelength. Although use of the lower-energy wavelength is not expected to increase the risk compared to the predicate device, the FDA may require clinical data to be submitted to demonstrate that the new device has an equivalent benefit-risk profile to the predicate device.

Scenario 2: Differences in technological characteristics

Significant change in:

  • Materials
  • Device design
  • Energy source
  • Device features

A submitter may wish to offer an implanted device in multiple sizes to an existing line of already cleared, implanted devices. There may not be any change to the design, materials, or device features, but if the new size establishes a new maximum or new minimum size such that it expands the range of device sizes, clinical data may be required to support determination of substantial equivalence.

Scenario 3: Substantial equivalence cannot be determined by solely nonclinical testing

  • No model (e.g., analytical, bench, animal) available
  • Available model may have certain limitations that do not allow for an adequate assessment
  • Available model may not be predictive of clinical outcomes
  • Anatomical and/or pathophysiological species-specific questions that rely on clinical evidence

A device may be intended for use in screening blood donors’ blood and blood products for transfusion-transmitted infections. Clinical data may be needed in this situation given that analytical testing is not available to evaluate the clinical performance of the assay and risks associated with incorrect results.

Scenario 4 (new): Newly identified or increased risk for the predicate device

  • Whenever possible, submitters should not select a predicate device if it has new or increased risks, particularly when another predicate device is available to use
  • However, if an alternative predicate device is not available without such risks, FDA may request that the submitter submit clinical data

A cleared device has been found to have an increased risk for patient injury during surgical procedures. In the predicate device’s 510(k) submission, nonclinical design verification and validation testing of the technological characteristics had been performed. The submitter then voluntarily recalls the device and submits a new 510(k) to address the increased risk observed. In its submission, it includes nonclinical and clinical performance data, for which the FDA has issued guidance for such testing for this device type.

The FDA will host a webinar on the draft guidances on October 26, 2023. Further, the FDA is accepting comments and suggestions on these draft guidances until December 6, 2023.

Contact the authors or another Goodwin Life Sciences Regulatory & Compliance team member with any questions you may have regarding the applicability of the guidances to your device or if you would like to submit comments on the guidances to the FDA.



[1] The third guidance in the trio, “Evidentiary Expectations for 510(k) Implant Devices,” complements existing device-specific guidances and is intended to serve as a “primary resource on general recommendations for all implant devices for which a 510(k) is required.”

[2] *When conducting a search, a submitter should review the following FDA databases:

**Information about emerging signals and safety communications is available on the Medical Device Safety and CBER Safety & Availability (Biologics) websites.

***Information about recalls is available on the Medical Devices Recalls Database.