Jan 25, 2019


  • 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Abbreviated 510(k) Program; the regulator first announced plans to expand the Abbreviated 510(k) Program and published draft guidance in early 2018.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.

Criteria for Safety and Market Pathway registration

FDA identifies three requirements that Safety and Market Pathway registrants must meet in order to utilize performance criteria to demonstrate substantial equivalence:

  • Submitted device’s indications for use and technological characteristics do not raise safety and effectiveness questions that differ from predicate device characteristics;
  • Performance criteria adequately relate to the performance of at least one legally marketed device of the same type as the submitted device;
  • Submitted device meets all performance criteria.

The agency plans to publish all performance criteria appropriate for use under the Safety and Performance Pathway through guidance and special controls. Applicants that cannot support device substantial equivalence claims using FDA-identified performance criteria do not qualify for the new pathway.

More transparent predicate device policies

Along with the rollout of its Safety and Performance Pathway, FDA has requested industry comment on its proposal to publicize 510(k)-cleared devices whose predicate devices are more than 10 years old.

Specific issues for which the regulator is seeking public feedback include whether to publicly list manufacturers whose cleared devices rely on older predicates; what, if any, additional or other criteria to use for such listings; which additional or alternative courses of action to take to boost safety and effectiveness of the 510(k) pathway; and whether to implement further actions such as stricter eligibility requirements for older devices to qualify as predicates.

“Older predicates might not closely reflect the modern technology embedded in new devices, or our more current understanding of device benefits and risks,” the agency states in its notice.

FDA is accepting comments through April 22, 2019.

Related US FDA 510(k) medical device regulatory resources:

  • FDA 510(k) consulting for medical device and IVD companies
  • FDA medical device classification support
  • FDA Pre-Sub (Q-Sub) consulting for medical device manufacturers
  • FDA 510(k) clearance calculator
  • Whitepaper: Preparing a US FDA 510(k) submission


  • Stewart Eisenhart