You are here
IDE Submissions Workshop - Spring 2020
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!
Feb 26, 2020 |
|
8:30 – 9:00 am |
Registration Check-In and Continental Breakfast |
9:00 – 9:05 am |
Welcome and Introductions |
9:05 – 9:45 am |
What Is an IDE?
|
9:45 – 10:00 am |
Break |
10:00 – 11:30 am |
Preparing the Technical & Functional Aspects of an IDE
|
11:30 – 12:15 pm |
Regulatory Compliance During Study Conduct
|
12:15 – 1:15 |
Networking Lunch |
1:15 – 2:00 pm |
Reporting Results
|
2:00 – 2:45 pm |
Optimizing the Pre-PMA Meeting
|
2:45 – 3:00 pm |
Break |
3:00 – 3:45 pm |
Developing an IDE Strategy
|
3:45 – 4:45 pm |
BIMO Audits
|
4:45 – 5:15 pm |
Speaker Q&A |
5:15 pm |
Adjournment |
The 510(k) Submissions Workshop will take place February 26 at the Courtyard Irvine Spectrum in Irvine, CA.
Click here to reserve your room
Room Rate: $199.00
Reservation Cutoff Date: Monday, February 3, 2020
Address:
7955 Irvine Center Drive
Irvine, CA 92618
Registration Fees
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 February 14, 2020 for $200 off your registration!