How to Format a Succinct and Comprehensive 510(k) Submission (Medical DeviceTraini)
Venue: Online Event
|Event Date/Time: Jan 17, 2012||End Date/Time: Jan 17, 2012|
Recently, the 510(k) program has been evolving (e.g., 510(k) actions and improvements). In addition, the recent FDA draft guidance document suggests that more 510(k) submissions be required to meet the regulatory requirements. It is imperative that medical device industry quickly recognize the recent changes in the 510(k) process, and understand and adapt to the recent changes/requirements to greatly facilitate the review in a proactive and streamlined manner.
This presentation is intended to demonstrate how to increase submission quality, which will subsequently prevent avoidable delays and reduce review times.