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510(k) Submissions Workshop - Spring 2020
FDA and industry experts are coming together to review the basics of 510(k) submissions. This unique opportunity will help you better understand the FDA perspective on 510(k) submissions, from processes to approval to modifications. Throughout the 2-day workshop, you'll obtain actionable insights and strategies for assembling and streamlining an effective 510(k) submission.
Agenda topics include:
- Guidance for 510(k): general & product specific
- Different types of 510(k)s
- Considerations for determining a product's regulatory route to market
- Factors to consider when planning and assembling a 510(k) submission (staff involved, RA responsibilities, etc)
- Tips and hints on interacting with FDA during the 510(k) review process
- Deciding when to submit a new 510(k) for a device modification
- And more!
Feb 24, 2020 |
|
8:30 – 9:00 am |
Registration Check-In and Continental Breakfast |
9:00 – 9:05 am |
Welcome and Introductions |
9:05 – 10:30 am |
The Law and Regulations
|
10:30 – 10:45 am |
Break |
10:45 – 12:15 pm |
510(k) Strategy and Planning
|
12:15 – 1:30 pm |
Networking Lunch |
1:30 – 3:15 pm |
Preparing the Submission
|
3:15 – 3:30 pm |
Break |
3:30 – 4:00 pm |
30 min exercise on 510(k) |
4:00 – 5:00 pm |
Networking Reception |
Feb 25, 2020 |
|
8:30 – 9:00 am |
Continental Breakfast |
9:00 – 10:45 am |
The FDA Review Process
|
10:45 – 11:00 am |
Break |
11:00 – 12:30 pm |
Clearance: Launch and After
|
12:30 – 1:30 pm |
Networking Lunch |
1:30 – 2:00 pm |
When to File a New 510(k) for Device Modifications
|
2:00 – 2:30 pm |
510(k) Post-Clearance Exercise Quynh Hoang, King & Spalding |
2:30 – 2:45 pm |
Break |
2:45 – 3:45 pm |
De Novo
|
3:45 – 4:30 pm |
Regulatory Strategy for De Novo
|
4:30 pm |
Adjournment |
- Sally Maher, Maher Consulting Group
- Wil Henderson, Hogan Lovells
- Angela DeMarco, FDA
- Tony Blank, Infinity Biomedical Group
- Quynh Hoang, King & Spalding
- Sergio de del Castillo, FDA
- Holly Drake, Dexcom
The 510(k) Submissions Workshop will take place February 24-25 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: $1395.00
Accel Member Registration: $695.00
Government and Non-Profit Registration: $695.00
Non-Member Registration: $1,895.00
Note: Early-bird pricing is available for AdvaMed Members and Non-Members. Register by February 14, 2020 for $200 off your registration!