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Frequently I am asked if minor device modifications, such as a color change, requires a new 510k submission. In general the answer is typically yes, and this surprises most manufacturers. In order to help make this decision, the FDA released a new draft guidance document in August (insert link). The current final guidance is titled “Deciding when to submit a 510(k) for a change to an existing device,” and that guidance is dated January 10, 1997. A draft guidance document on this topic was released in several years ago, but that draft guidance was withdrawn in response to feedback from industry.
The new draft guidance document includes modified decision trees to help manufacturers decide which types of changes will require a new submission, but there are also examples provided in Appendix A. The most helpful part of the guidance, however, is Appendix B. Appendix B explains how to document changes properly—regardless of whether a change requires a submission or not.
Typically adding a colorant, or changing a colorant, does not negatively impact strength of a device but this is the first cautionary statement made at the beginning of the section for material changes. Sometimes large concentrations of colorant result in weakening of plastics. Therefore, repeating some of the performance testing or providing data that supports the need for no further testing is expected. In the decision trees performance is addressed by question C5, “Could the change affect performance specifications?” If no, then you document the change but a new 510k is not required. If yes, then you refer to decision tree question B5.
The next concern addressed by Decision Tree C is the biocompatibility of your modified device. If the material change of the device or device component comes into direct contact with the body, blood or tissues then biocompatibility risks must be assessed. If the change does create new or increased issues related to biocompatibility then question C4.1 asks, “Has the manufacturer used the same material in a similar legally marketed device?” If the changed material has not been used previously for a similar application, then a new 510k is required—typically a Special 510k if only the material is changed and only biocompatibility needs to be assessed by the FDA.
Within the guidance document, the FDA explains that you may want to refer to “Use of International Standard ISO 10993-1, ‘Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,’” (insert link) when you are answering question C4. This new final guidance was released on June 16, 2016 and the Office of Device Evaluation (ODE) appears to be focusing much more closely on biocompatibility since this new guidance released.
If you have other questions about biocompatibility or 510k submissions, on December 1 @ 11am EST I will be hosting a new live webinar on the topic of biocompatibility. The webinar will address both requirements for 510k submissions and for CE Marking technical files. If you are interested in registering for that webinar, please click on the following link:
You might also be interested in our 510k course series (Special Price of $1,200…):
You gain access to 24 webinars related to 510k submissions, the new 510(k) book and 510(k) templates.
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