510(k) Change Analysis - Webinar Recording/Transcript
510(k) Change Analysis: Key Takeaways from the Final Guidance
On Nov. 8, the FDA is expected to issue twin final guidances revamping the device change process and determining when a new 510(k) is required.
We explain it all to you ... and outfit you with tools to comply.
Background: The 21st Century Cures Act mandates new guidances to replace protocols in place for as long as 20 years. One guidance is expected to cover general changes, the other changes specific to software.
Look for: A focus on risk management ... clarification of many issues including QSR in the analysis ... extensive use of flow-charts ... and changes to documentation protocols.
Top presenter Dan O’Leary has followed this matter every step of the way. He is readying an Excel workbook that implements the logic in the flow charts, guides the user through the decision-making process, and shows the decision path if a new 510(k) is required.
This workbook will be yours FREE when you sign up for this presentation.
Get ready to discover:
- The FDA’s plans for evaluation of changes
- Role of risk management (ISO 14971:2007) in the evaluation process
- The decision-making process embodied in the flow charts
- The criteria behind the flow-chart decision boxes
- How to establish the quality record to support your decision
- And much more!
Remember, it’ll be a different world after Nov. 8. It’s on you to be in compliance, and any failure could delay getting changed products to market. There’s no point taking a risk.