FDA posts final guidance for new 510(k) pathway

By Erik L. Ridley, AuntMinnie staff writer

January 23, 2019 -- The U.S. Food and Drug Administration (FDA) has published its final guidance on a new regulatory pathway that would allow manufacturers to show that their medical devices meet specific performance criteria to achieve 510(k) clearance.

Instead of the traditional 510(k) process requiring that vendors show their product has "substantial equivalence" to a specific previously cleared device, the FDA's new Safety and Performance Based Pathway would enable manufacturers of new devices 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, according to the FDA.

This model expands upon the approach used in the FDA's Abbreviated 510(k) program. The FDA noted that it may request and review underlying data and testing methodologies to determine under this program whether a new device is substantially equivalent.

The FDA also said that it intends to periodically review device types and applicable performance criteria to ensure they remain appropriate. The final guidance can be found on the FDA's website. Device types and applicable performance criteria will be shared in future guidances.

Separately, the FDA is requesting comments on approaches to drive companies to develop and offer patients devices with the latest technological advances. Specifically, the FDA is requesting feedback on the following questions:

  • Should the FDA make public a list of devices or manufacturers that 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 its point of reference?
  • Are there other actions the FDA 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?

Comments on these topics must be submitted to the FDA docket by April 22.


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