Speaker: Rob Packard
Description: Do you know how to prepare your own 510(k)? Each year 99% of devices are cleared by the FDA with a 510(k) submission. Without a proper understanding of the process, your product launch could end up costing significantly more and delayed by several months. In addition to understanding the 510(k) process, you also need to know when your device is part of the 1% of devices that require a De Novo Classification Request. This webinar will outline AAMI’s new, highly demanded, Navigating 510(k) & De Novo Requirements course that will be held May 18-21, 2020 in Arlington, VA.
- Recognize the differences and similarities between the 510(k) & De Novo application processes
- Establish the pros and cons of choosing De Novo over 510(k)
- Understand the 15 “need-to-know” factors to be successful in both 510(k) and De Novo submissions