The FDAs New Draft Guidance on Medical Device Change(s) and the 510(k) (Medical DeviceTraini)
Venue: Online Event
|Event Date/Time: Oct 04, 2011||End Date/Time: Oct 04, 2011|
Areas Covered in the Seminar:
- Key requirements of the new Draft Guidance on Changes and the 510(k).
- Fully capture your device change control process.
- Expected sources of information for evaluation and inclusion.
- Two approaches to the use of FDA's K97-1 Memo.
- Step-by-step analysis: Manufacturing, Labeling, Tech / Performance, and/or Materials Changes.
- Change reporting "tipping point" -- with one change or cumulative.
- Which of the three major 510(k) formats should be used.
- How to complete, document and control as a 'living' document