Thursday, 10 October 2019 (8:00 AM) - Friday, 11 October 2019 (3:30 PM) (Amsterdam)
Damrak 1-5, 1012 LG
REGISTRATION NOW OPEN!
Through 8 September 2019
From 9 September 2019 through 4 October 2019
*Netherlands charges 21% VAT
Most medical devices in the US today are marketed under the premarket notification 510(k) authorities of the Federal Food, Drug, and Cosmetic Act). To market some types of Class I and most Class II devices in the US, you need to submit a 510(k) submission to FDA and receive FDA clearance. While the underlying data used to support the 510(k) submission may be similar to requirements in other jurisdictions, the regulatory requirements and the submission process are very different. The purpose of this workshop is to provide participants with an understanding of the regulatory fundamentals; practical guidance on how to develop, prepare and submit a 510(k) to FDA; and how to engage with FDA.