FDA plans to expand the abbreviated 510(k) program for medical devices

The United States (US) Food and Drug Administration (FDA) is seeking to expand its abbreviated 510(k) premarket review program to meet least burdensome principles and expedite market access for qualifying medical devices. The expected aims of expanding the abbreviated premarket notification pathway are to provide faster US market access for some devices and streamline FDA review activities.

New draft guidance from the FDA may allow qualifying US medical device market registrants to utilise methods such as conformity to FDA-recognised consensus standards, FDA guidance and special controls to show that their products meet all performance characteristics required to support Substantial Equivalence (SE) claims. At present, the abbreviated 510(k) program entails direct comparisons of specific sets of performance criteria between applicants’ devices and predicate devices incorporating technologies or designs that in some cases may be too dissimilar or outdated.

Through expansion of the abbreviated 510(k) program, FDA aims to streamline the review of 510(k) applications and reduce the time to market for registrants, as well as increasing transparency regarding the criteria for devices that are cleared through the abbreviated review pathway.

The FDA has identified three conditions that 510(k) applicants should meet in order to use performance criteria:

  • The device’s indications for use and technological components do not differ in terms of safety and effectiveness than that device’s identified predicate.
  • The device’s performance criteria match those of at least one legally marketed product of the same device type.
  • The device meets the performance criteria in question.

The draft guidance states that devices which are unable to completely rely on the performance criteria required to meet SE requirements do not qualify for the expanded abbreviated 510(k) program, and thus it is advised they should undergo the traditional, special or non-expanded abbreviated 510(k) review.

The FDA plans to provide further guidance on performance criteria applicable to device types that are best suited to the expanded abbreviated premarket notification program.

The FDA recommends that if applicants are unsure as to whether their devices qualify for the expanded abbreviated 510(k) pathway, they should utilise the FDA’s Q-Submission (Q-Sub) premarket consultation option to discuss whether their submissions meet the program’s requirements.

To view the draft guidance from the FDA entitled ‘Expansion of the abbreviated 510(k) program: Demonstrating substantial equivalence through performance criteria’, please click here.