This webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results-driven 510(k) / change analysis activities, based on the U.S. FDA has its current two recent “Final Guidance for Industry and FDA Staff”: “Deciding When to Submit a 510(k) for a Change to an Existing Device”; and “Deciding When to Submit a 510(k) for a Software Change to an Existing Device“; both dated November 16, 2017. The webinar will discuss how companies can best navigate the decision process using these guidance documents, alternatives necessary to address the inevitable “gray” areas successfully, and then document their decision when a new 510(k) filing is warranted. It will assist in the implementation of formal methods with documented, and defensible rationale; which will also prepare the industry for further 510(k) changes in the future. This applies to companies in the Medical Device and combination products fields.The FDA had published its K97-1 Memorandum, draft guidance, and finally two recent final guidances to assist companies to a correct decision as to when a major device change or a series of lesser changes finally trigger the need to file a new 510(k).Areas CoveredThe important formal CGMP-compliant Change Control system and its documentationKey requirements of the two recent Final Guidance on Changes and the 510(k) and Safety and EfficacyAddressing the single triggering change, and the tipping point after a series of device changes (software and/or hardware)Expected sources of information for evaluation and inclusionStep-by-step analysis: Manufacturing, Labeling, Tech / Performance, and/or Materials ChangesA risk-based phased approach, and the only FDA-acceptable meaning for “risk-based”Change reporting "tipping point" -- with one change or cumulativeWhich of the three major 510(k) formats should be usedHow to complete, document and control as a 'living' documentCourse Level - Beginner to IntermediateWho Should AttendThis webinar will provide valuable guidance to regulated companies in the development and implementation of formal, defined, documented methods for the analysis of product changes and when to file a new 510(k). Consideration of the U.S. FDA's current final guidance documents of device changes, and tools available / encouraged in the CGMPs, will provide tools to document such decisions.Design and Manufacturing EngineersComputer programmers and TestersQA/QC/RAMarketingManagement and Supervisory PersonnelOperationsR&DWhy Should You AttendControl of medical device changes and a current 510(k) are big issues in recent FDA studies. Companies are held fully responsible for deciding when a new 510(k) filing is warranted. Often this is a difficult decision process. Effective change control and the power of current risk management tools must be a major part of such an analysis. The U.S. FDA has its current two recent “Final Guidance for Industry and FDA Staff”: “Deciding When to Submit a 510(k) for a Change to an Existing Device”; and “Deciding When to Submit a 510(k) for a Software Change to an Existing Device“; both dated November 16, 2017, designed to strengthen the 510(k) process. These documents supersede “Deciding When to Submit a 510(k) for a Change to an Existing Device, dated January 10, 1997. These Guidances provide companies tools to perform meaningfully, results-driven 510(k) / change analysis activities, but still “gray” areas. How can companies utilize these tools, and successfully address the remaining “gray” areas? The addition of simple tools will assist companies in implementing formal, documented, repeatable methods with defensible rationale for their decisions on when a new 510(k) needs submission.