Topics
- Premarket Approval submission
- K submission
- When between a PMA and 510k, submitting a 510K is appropriate?
- History of the 510k since it was initially created in 1976
- Failure to submit a 510K - individual(s) responsibility, corporate responsibility, criminal prosecution and penalties
- PMA versus a 510K - time and cost factors
- When not to file a 510K in Class I and Class II devices
- Civil penalty, civil action and injunction action
- Managing FDA inspection when 510K is not files
When Do You Need a 510K? brings together Product Development Managers, echnical Directors / VP`s, Compliance Directors/Managers, Operations / Production Managers, Marketing and Regulatory Affairs/ Quality.
