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RAPS European Workshop on 510(k) Basics and Working with FDA

RAC Credits
Thursday, 10 October 2019 (8:00 AM) - Friday, 11 October 2019 (3:30 PM) Central European Time
Damrak 1-5, 1012 LG
Amsterdam, Netherlands

Hotel Reservations


Through 8 September 2019
Member: €850
Nonmember: €950
From 9 September 2019 through 4 October 2019
Member: €950
Nonmember: €1050

*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.
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