USA – US FDA Pushes 510(k) Performance Criteria, Predicate Device Policy Changes

  • US FDA finalizes Safety and Performance 510(k) registration route;
  • Performance criteria to play greater role in substantial equivalence for qualifying devices;
  • 510(k) predicate device policies still slated for revision.

The US Food and Drug Administration’s medical device oversight division has rolled out final guidance on an expanded 510(k) registration route retooled to focus on device safety and performance issues, and is seeking industry comment on proposed changes to its predicate device policy.

FDA’s Safety and Performance Pathway finalized

FDA’s final guidance on what the agency calls its Safety and Performance Pathway is based on the Abbreviated 510(k) Program; the regulator first announced plans to expand the Abbreviated 510(k) Program and published draft guidance in early 2018. Through this market authorization pathway, qualifying device manufacturers would be able to utilize performance criteria identified and approved by FDA to demonstrate Substantial Equivalence.

Citing Least Burdensome provision obligations, FDA argues in its final guidance that alternative options to demonstrating substantial equivalence via comparisons to predicate devices are necessary for some US market applicants. In such cases, applicants would have the option to utilize performance criteria rather than direct comparison testing to predicate devices in order to meet substantial equivalence requirements:

“Instead of reviewing data from direct comparison testing between the two devices, FDA could support a finding off substantial equivalence based on data showing the new device meets the level of performance of appropriate predicate device(s),” states the guidance.

The Safety and Performance Pathway approach to substantial equivalence stems from FDA’s Abbreviated 510(k) Program, wherein applicants demonstrate conformity to agency-recognized consensus standards, regulatory guidance or special controls in order to support their substantial equivalence claims…