On August 8, 2016, the FDA released a draft guidance for Industry and Food and Drug Administration Staff regarding when to submit a 510(k) for a change to an existing device. When final, this document will supersede the guidance Deciding When to Submit a 510(k) for a Change to an Existing Device released January 10, 1997.
When finalized, this guidance will represent the current outlook of the FDA on this issue. FDA is issuing this draft guidance document to clarify when a change in a legally marketed medical device would require that a manufacturer submit a premarket notification (510(k)) to FDA. By comparing the 1997 Guidance to the recent draft guidance, the FDA preserves the basic format and content but includes much needed updates for clarity and more consistent interpretations.
The 2016 version of the guidance provides more depth on determining whether to submit a new 510(k). Any modification that is intended to significantly affect safety or effectiveness of the device will likely require a new 510(k) application. The FDA encourages using risk management as an evaluating tool and each change should be assessed individually as well as in the aggregate. When submitting a new 510(k), the FDA recommends describing all changes that require a new 510(k) as well as those that do not and fully document the decision making behind that choice. Furthermore, changes that do not require a new 510(k) submission may be implemented immediately as long as those changes do not effect ones that require a new 510(k) submission.
The 2016 version, similarly to the 1997 guidance, employs the use of flow charts to aid in the 510(k) decision making process. The draft guidance includes multiple flow charts and text to guide manufactures to a decision. The flow charts in the guidance include labeling changes; technology, engineering and performance changes; material changes; technology, engineering, performance, and materials changes for in vitro diagnostic devices; and considerations for risk assessments of modified devices. Furthermore, each flow chart ends with either ‘New 510(k)’ or ‘Documentation’ for conciseness and text that expands on the decision making points. The new draft guidance also includes over 30 examples to aid in the decision making process including examples from recent court cases.
The 2016 version includes many favorable updates to the existing guidance and AlvaMed is here to help guide you and your organization through all of the upcoming changes.
To read the draft guidance in its entirety: