FDA announces steps to strengthen its 510(k) pathway by promoting the use of robust performance criteria and modern predicate devices

In April 2018, the U.S. Food and Drug Admnistriation (FDA) issued a Medical Device Safety Action Plan, in which the Agency committed to strengthen and modernize its 510(k) program. The FDA believes the most impactful way to promote innovation and improve safety in the 510(k) program is to encourage medical device manufacturers toward reliance on robust performance criteria and more modern predicate devices when they seek to bring new devices to patients.  Today we are taking the next steps to implement the actions described in the joint statement from FDA Commissioner, Scott Gottlieb, and Center for Devices and Radiological Health (CDRH) Director, Jeff Shuren, issued on November 26, 2018.

Safety and Performance Based Pathway

Today, the FDA issued and posted on the agency’s website final guidance establishing the framework for the Safety and Performance Based Pathway. This guidance has been renamed from the draft guidance entitled “Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria” to reflect FDA’s focus on advancing improved safety and performance of new products.

This Safety and Performance Based Pathway expands the approach long applied through the Abbreviated 510(k) Program, which is based on conformity to FDA-recognized consensus standards. Under the Safety and Performance Based Pathway, a manufacturer would have the option to demonstrate aspects of substantial equivalence by showing that a new device meets FDA-identified performance criteria that reflect current technological principles and the safety and performance of modern predicate devices. Consistent with current policy, the FDA may request and review underlying data and testing methodologies as necessary to find that a new device is substantially equivalent under this program. The FDA intends to periodically review the device types and applicable performance criteria to ensure they remain appropriate.

The FDA plans to identify the types of devices and the applicable performance criteria  for the Safety and Performance Based Pathway through future guidance. Upon publication of the first device-specific guidances, the FDA will communicate with stakeholders and will hold a webinar to further explain how the Safety and Performance Based Pathway will be implemented. The FDA intends to identify performance criteria for certain device types through guidance, which includes an opportunity for input from stakeholders, and welcomes evidence-based suggestions on what the performance criteria should be for such device types. We encourage stakeholders to provide their suggestions and comments using the docket number FDA-2018-D-1387.

Promoting the use of more modern predicate devices

In a separate action, the FDA has issued a notice on the FDA website and opened a docket requesting comments regarding approaches to drive sponsors to offer patients devices with the latest improvements and advances. One possible way to advance this goal is FDA’s consideration to publicly post on its website a list of FDA-cleared devices that demonstrated substantial equivalence to older predicate devices. As described in the November 26 joint statement from the FDA Commissioner and CDRH’s Director, the FDA is requesting feedback on the following topics:

Should the FDA make public a list of devices or manufacturers who make technologies that rely on predicates that have been on the market for more than a certain number of years (e.g., 10 years)? If so, what would be an appropriate period of time?

  • Should the FDA consider using other criteria to inform our point of reference?
  • Are there other actions we should take to promote the use of more modern predicates?
  • Should the FDA consider certain actions that might require new authority, such as making at least some older devices ineligible as predicates?

The FDA is requesting that comments be submitted to the docket number FDA-2018-N-4751 by April 22, 2019.

If you have any questions, please contact the 510(k) Staff at 301-796-5640 or at 510K_Program@fda.hhs.gov.

Food and Drug Administration
Center for Devices and Radiological Health