Medical Device Change Control and FDA Submissions
This course is intended to provide an overview of 2 new FDA draft guidance documents that clarify when medical device and software manufacturers must file a 510(k) (premarket notification) for changes to an existing device and/or software integrated with a device. The FDA notes that while neither of these drafts specifically includes combination products, the general concepts may be helpful in determining whether changes to device constituent parts of combination products need a 510(k). The critical decision is whether a proposed change to a legally marketed medical device subject to premarket notification requirements is significant enough to require FDA review. This includes any major change or modification to the intended use of the device that could have an impact on patient safety and effectiveness. In this webinar expert speaker Carolyn Troiano will aid manufacturers of medical devices who intend to modify a 510(k)-cleared device or a preamendments device subject...