It has been a long journey for the FDA to get the new draft guidances published on when to submit a 510(k) for a change to an existing device, and another specific to software changes. But on August 8th, 2016 it finally happened! For those of you who remember the FDA's attempt at updating the 1997 Memorandum in 2011, that draft guidance was met with general industry pushback, congressional input, an FDA report to congress, and now a new draft guidance.
The Documents
Deciding When to Submit a 510k for a Change to an Existing Device
Deciding When to Submit a 510(k) for a Software Change to an Existing Device
The new draft guidance incorporates the flowcharts that were integral to the 1997 version while adding significant guidance and text to support each decision block in the flow diagram. Central to the theme throughout the new guidance is to assess whether or not the change impacts risk assessment: “identify a new or significantly modified risk." In 1997 the guidance changes related to “material type” and were less specific than the new guidance, where now the first question includes “material type, formulation, chemical composition, or the materials processing” and seems to encompass changes that may in the past have not been included in “material type." Additionally, any verification or validation efforts to support the change that result in unexpected issues would trigger the need to file a new 510k. The expectation with each change is that the individual change is reviewed in addition to a review of the cumulative changes made since the device was cleared.
For software changes, the new guidance again focuses on the impact to the risk assessment in determining if a 510(k) is needed. It provides specific types of software changes including infrastructure, architecture, core algorithm, cosmetic changes, reengineering and refactoring, among others.
What To Do
When the guidance issues in final format, your procedure for assessing a change would do well with a refresh. Examples of assessments are provided in Appendix B (Appendix A for software) of the guidance and can easily be converted to a template to be used for “Letters to File." The risk with any new guidance, of course, is what about all of the changes that have been made under the old guidance that - according to the new guidance - would have resulted in a different decision?
Although the 1997 guidance is still in effect, until this guidance is finalized, starting to move your Quality System and Regulatory Assessments to the current thinking will help you in the long run. A well-documented decision with justifications will be easier to defend than a flow-chart without text, one of the chief complaints of how the previous version was implemented. For those products that are critical to your business and have a stack of “letters to file,” it may be time to start thinking about how you will assess the next change and should you be planning a new submission to start covering some of those incremental changes.
10 Tips
While we encourage you to contact us directly for assistance with these new draft guidances, you can immediately grab our our 10 Tips for Successful 510(k) Submissions below.