The 510(k) submission process is preferred over a PMA for those devices that qualify. Would you know which 510(k) to use? What is involved or how do you plan for a submission? Are you sure your submission can get clearance from the FDA?
In this 90-minute audio conference sponsored by Medical Device Daily, device submissions expert Karen Bannick will discuss what is expected in 510(k) submissions and how you can effectively respond to the agency's ever increasing demands for more medical and scientific information.
"510(k)-Essentials of Gaining FDA Marketing Clearance" is just $325 per listening site. Scheduled for March 12th, from 2:00 pm to 3:30pm ET, it includes presentation handouts and a Q&A session with the speaker. A conference CD (MP3 format) is also available. Please call 800-688-2421 or 404-262-5474 and mention conference code T09542.