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.
Past Events
Webinar: When Do You Need a 510K? 2012 - 07 Mar 2012, Webinar (25968)
Webinar: When Do You Need a 510K? 2026
Important
Please, check "Webinar: When Do You Need a 510K?" official website for possible changes, before making any traveling arrangements
