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FDA Moves Closer to Modernizing 510(k) Program

FDA took the next steps this week toward establishing the framework that is now being called the Safety and Performance Based Pathway. The agency also is seeking input from the industry on its plan to promote the use of more modern predicate devices in the 510(k) program.

FDA issued final guidance this week establishing the framework for what is now being called the Safety and Performance Based Pathway. The guidance was previously dubbed Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria.

This guidance is part of FDA's Medical Device Safety Action Plan that was first announced in April 2018. FDA Commissioner Scott Gottlieb and Jeff Shuren, director of the Center for Devices and Radiological Health, also described specific actions within the plan in a joint statement on Nov. 26, 2018. The guidance issued this week represents the next steps in implementing those actions, the agency noted.

Under the new 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, 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 agency said it intends to periodically review the device types and applicable performance criteria to ensure they remain appropriate.

FDA said it 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 agency said it will communicate with stakeholders and will hold a webinar to further explain how the new pathway will be implemented. FDA said it 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.

Medical device companies and other stakeholders can make suggestions and comment on the plan using the docket number FDA-2018-D-1387.

Promoting Modern Predicate Devices

In a separate action this week, FDA also issued a notice 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, according to the agency, is for FDA to publicly post on its website a list of FDA-cleared devices that demonstrated substantial equivalence to older predicate devices. Specifically, 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?

Medical device companies and other stakeholders can submit feedback on these questions to the docket number FDA-2018-N-4751 by April 22.

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