During this interactive workshop, FDA and industry experts will lead you through the regulatory and practical guidelines governing when an investigational device exemption (IDE) is required.
Agenda topics include:
- The purpose of an IDE
- Tips on making the best use of pre-submission meetings
- Components of a successful IDE submission
- Common errors and deficiencies in an IDE application
- The ins and outs of BIMO inspections
- Details about the regulatory requirements needed during trial conduct
- And more!
The 510(k) Submissions Workshop will take place November 26 at the Courtyard Irvine Spectrum in Irvine, CA.
Room Rate: $174.00
Reservation Cutoff Date: Monday, February 3, 2020
7955 Irvine Center Drive
Irvine, CA 92618
AdvaMed Member Registration: $795.00
Accel Member Registration: $595.00
Government and Non-Profit Registration: $595.00
Non-Member Registration: $1,095.00
Note: Early-bird pricing is available for AdvaMed Members and Non-Members. Register by January 25, 2019 for $200 off your registration!