Oct 3, 2018


  • US FDA launching pilot program to expand Special 510(k) route for modifications to medical devices.
  • Pilot would allow more types of device changes to qualify for simplified Special 510(k) route.
  • All Special 510(k) submissions received by FDA from October 1, 2018 will be considered for participation in pilot.

Medical device regulators at the US Food and Drug Administration has initiated a new pilot program for expanded eligibility in the agency’s Special 510(k) pathway, potentially easing market compliance requirements for more manufacturers whose devices have undergone modifications.

FDA’s Special 510(k) Program Pilot would allow more types of changes to registered devices to qualify for the simplified Special 510(k) pathway, designed for simplified regulatory clearance of modifications to devices that have already obtained premarket notification. All Special 510(k) submissions to FDA from October 1, 2018 will be considered for inclusion in the pilot, with the goal of increasing overall utilization of this 510(k) route.

Design, labeling changes to qualify for Special 510(k) review

Under the Special 510(k) pilot, FDA will allow certain design and labeling modifications that previously required Traditional 510(k) clearance.

“The Agency believes that the reliance on design control requirements and previous Agency review of detailed information can reduce review times and still protect the public health,” FDA states.

FDA also plans to host a webinar on the new pilot program in November 2018.

Special 510(k) program pilot criteria

Eligibility for the new pilot depends on three criteria identified by FDA:

  • Proposed changes to device in question have been submitted by the manufacturer that holds 510(k) clearance for that device;
  • Performance data is either unnecessary or may be evaluated using well-established, available methods;
  • Performance data required to support Substantial Equivalence may be reviewed in summary or risk analysis formats.

Any device modifications that do not meet these requirements will have to undergo Traditional 510(k) review.

Broader FDA efforts to streamline 510(k) market pathway

FDA’s new Special 510(k) pilot follows a similar proposal to expand the agency’s Abbreviated 510(k) regulatory pathway earlier in 2018. These moves indicate the regulator’s ongoing efforts to boost efficiency in its most widely used market authorization route.

Related FDA 510(k) resources from Emergo:

  • US FDA 510(k) consulting for medical device and IVD companies
  • FDA medical device classification support
  • Medical device design, process and software validation services
  • Whitepaper: Preparing a US FDA 510(k) submission
  • Video overview: US FDA medical device regulatory process


  • Stewart Eisenhart