PATHWAY TO THE U.S. MARKET – HOW TO PREPARE A SUCCESSFUL 510(K) FOR YOUR DEVICE – upon request

In this training session, you will learn how to bring Class II devices to the U.S. market under the 510(k) program. Topics such as device classification, the concept of substantial equivalence, device specific guidelines, choosing a 510(k) pathway, preparing a 510(k) submission and how to submit a e-copy compliant 510(k) submission to FDA will be discussed. This training session does not require any prior knowledge of US medical device regulations and will give you the information required to prepare your first 510(k) or to improve your next 510(k). Through this training, you will learn to develop a submission strategy as well as how to draft a 510(k) with a lean efficient approach.

•Opening remarks
•Background of 510(k) program
•510(k) Pathways
•Device Classification
•Drafting the 510(k) Sections
•Incorporating relevant FDA guidance and usage of consensus standards
•Submitting a 510(k) to FDA
•Responding to deficiency letters
•Q&A session
•Closing remarks

• Start 02:00 PM – End 06:00 PM. Attendees are recommended to login 15 min in advance.

In order to keep the training interactive, the exact content schedule cannot be provided.