In its continued effort to reduce time to market for regulated products and improve transparency, the Food and Drug Administration (FDA) published a draft guidance last Friday that, among other things, proposes to (i) expand the Special 510(k) Program to allow manufacturers to submit certain changes to a product’s indications for use that are not within the scope of the current Program, and (ii) clarify the types of technological changes that are eligible for the updated Program. Today, FDA announced a Special 510(k) Program Pilot to test the proposed Program's efficiency. The Special 510(k) Program allows manufacturers to obtain clearance of their modified devices on an expedited basis. All Special 510(k) submissions received on or after October 1, 2018 will be reviewed under the Pilot. If you plan to make modifications to an existing device going forward, you may want to explore whether your modification can take advantage of the Special 510(k) expedited review process.

Under the updated Program, FDA will evaluate whether a device change is eligible for a Special 510(k) by focusing on whether the methods to evaluate the change are well established and whether the results can be reviewed in summary or risk analysis format. Regarding modifications to design or labeling, including indications for use, the Guidance proposes that such changes may be appropriate for a Special 510(k) where: 

  • The change is submitted by the manufacturer legally authorized to market the previously cleared device
  • All performance data is either:
    • Unnecessary (for example, where the submitter can provide a sufficient scientific rationale to justify making the change without testing) or
    • Based on well-established methods to evaluate the change, which can include:
      • The methods, protocols and acceptance criteria used for the testing the predicate device or
      • Methods found in FDA recognized voluntary consensus standards or
      • Widely available and accepted methods published in the public domain or previously found acceptable by FDA through a premarket submission, and
  • All performance data necessary to support a substantial equivalence determination can be reviewed in summary fashion, that is, FDA does not need to interpret the underlying data

The Guidance also fills in the gaps regarding the information needed in a summary or table, but expressly recognizes that there may be different approaches to design control activities and verification and validation summaries based on the manufacturer’s quality system. In addition, the Guidance provides examples of changes that continue to be ineligible for Special 510(k) review, such as where a company recently was issued a violative inspection report based upon observations related to design controls that are relevant to the design changes under review in the 510(k), updates the flow chart for when device changes are eligible for a Special 510(k), and provides examples of real-world design control activities summaries that it found to be acceptable.

With respect to indications for use changes, the Guidance clarifies that FDA anticipates needing full test reports for changes that are supported by clinical, animal or cadaver data, and accordingly, the Special 510(k) Program would not be appropriate for these types of changes. In addition, the examples indicate that changes from general to specific indications for use to identify a specific disease condition also continue to be inappropriate for the updated Program.