FDA Announces Special 510(k) Program Pilot


Posted October 2, 2018

The FDA has announced the launch of a pilot program that would test an expansion of the agency’s Special 510(k) premarket clearance process, an optional—and faster—pathway to clearance for certain well-defined modifications to a manufacturer’s own medical device. All Special 510(k) submissions received on or after Oct. 1, 2018 will be included in the program pilot, according to the FDA.

“The goal of the pilot is to determine whether updated factors for eligibility in the Special 510(k) Program will improve the FDA staff’s efficiency in reviewing 510(k) submissions,” the FDA wrote in an emailed statement. “The FDA would like to increase the number of 510(k) submissions that are appropriate for the Special 510(k) Program.”

The FDA described the proposed expansion of the program in draft guidance, The Special 510(k) Program.   

As established by the Medical Device User Fee Amendments of 2017 (MDUFA IV), the FDA is working to reduce the amount of time it takes to make 510(k) decisions to fewer than 108 calendar days. Special 510(k) submissions are generally reviewed within 30 days, according to the draft guidance.

Under the current Special 510(k) Program, premarket submissions are often converted to a traditional 510(k) submission—and thus delayed—when the submission includes changes to the device’s indication for use or in the “fundamental scientific technology of the device,” the FDA wrote. Under the proposed update to the Special 510(k) Program, manufacturers making a design or labeling change to an existing device (including certain changes to indications for use) can have that device reviewed under the faster Special 510(k) Program so long as the following conditions are met:

  • The proposed change is made and submitted by the manufacturer authorized to market the existing device.
  • Performance data are unnecessary, or if performance data are necessary, well-established methods are available to evaluate the change.
  • All performance data necessary to support substantial equivalence can be reviewed in a summary or risk analysis format.

The draft guidance includes a question-and-answer section and flowchart to help manufacturers determine if their device is eligible for the program.

Once finalized, the Special 510(k) Program would replace a 1998 guidance document, The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications with the exception of that guidance’s description of the Abbreviated 510(k) pathway, which will remain in effect.

The FDA is accepting comments on the draft guidance until Nov. 27 at www.regulations.gov (docket FDA-2018-D-3304) The FDA will also host a webinar to answer questions about the pilot program on Nov. 8.