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FDA’s Special 510(k) submission process has been around for years as an expedited method to demonstrate that the device to be marketed is at least as safe and effective (i.e., substantially equivalent), to a legally-marketed device not subject to the Premarket Approval (PMA) process.

In September 2019, a modified version of this program was published to create a streamlined review of technological changes made to a manufacturer’s own cleared device which leveraged design control requirements. In its original form, changes reviewed under the Special 510(k) program were limited to those that did not affect the intended use of the device or alter the fundamental scientific technology. Over years of use, many sponsors experienced frustration with Special 510(k)s being converted to Traditional 510(k)s because the FDA wanted to review the data associated with a change, even though it met the criteria and did not affect the indications for use or the fundamental scientific technology.

In response to pressure and recommendations from industry and Congress, the FDA recently updated its Special 510(k) guidance document to reflect a change in focus (www.fda.gov/media/116418/download). The agency will now determine the acceptability of a Special 510(k) based on the answers to four questions:

  • Is it a change to the manufacturer’s own device?
  • Are performance data needed to evaluate the change?
  • Is there a well-established method to evaluate the change?
  • Can the data be reviewed in a summary or risk analysis format?

There are not many differences between the previous draft and the final guidance. The overall basis for when a Special 510(k) may be appropriate is unchanged:

  • “The proposed change is submitted by the manufacturer legally 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; and
  • All performance data necessary to support SE [substantial equivalence] can be reviewed in a summary or risk analysis format.”

To learn more about the Special 510(k) update and the filing process, or for assistance with any of your regulatory needs, contact Susan Reilly at SReilly@MEDIcept.com.