Free webinar on 510(k) process

ALL finished medical device contract manufacturers and contract sterilisers (both domestic and foreign entities) must register with the U.S. Food and Drug Administration for fiscal year 2013, or beginning in October 1, 2012. An important part of this registration process is the 510(k) number for medical devices. In this one-hour webinar on October 3 (12:00 EDT/16:00 GMT), Emergo will break down the FDA device clearance process into understandable steps and explaining each one:

? Overview of the U.S. medical deviceclassification scheme

? What is Post Market Notification 510(k)?

? Do you have a predicate device with the SAME intended use?

? How to determine proper classification and Product Codes for your device

? Major sections of the FDA 510(k) application

? Common mistakes made during the 510(k) preparation process

? Discussion about FDA guidance documents and testing requirements

? C o m p l i a n c e w i t h F D A G o o d Manufacturing Practice (21 CFR Part 820)

? Appointing a U.S. Agent for non-U.S. companies

? Establishment Registration process with the US FDA

? Fees and timelines

This webinar will be conducted in English. Register now at: www2.emergogroup.com/webinar-us-510k-oct-2012