510(k) Submissions Workshop - Spring 2020

February 24, 2020 to February 25, 2020

Irvine, CA

Overview
Agenda
Speakers
Event Logistics
Additional Info

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!

View the full agenda

*Download the full agenda* 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 Sally Maher, Maher Consulting Group 510(k) definition 510 and 513 FDCA Guidance for 510(k): general & product specific How to find it How to use it Different types of 510(k)s; which to use Review of bundling 510(k)s CDRH organizational structure FDA Product Codes - activity
10:30 – 10:45 am	Break
10:45 – 12:15 pm	510(k) Strategy and Planning Sally Maher, Maher Consulting Group Staff involved Role of each function RA responsibilities Use of guidance Global considerations Pre-submissions Predicates
12:15 – 1:30 pm	Networking Lunch
1:30 – 3:15 pm	Preparing the Submission Wil Henderson, Hogan Lovells General information including how to select a predicate device Assembling the 510(k) eCopy
3:15 – 3:30 pm	Break
3:30 – 4:00 pm	30 min exercise on 510(k) Wil Henderson, Hogan Lovells
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 Angela DeMarco, FDA How it works at FDA FDA/industry interactions Refuse to Accept Submission Issue meetings FDA holds Interactive review Least Burdensome flag Current pilots
10:45 – 11:00 am	Break
11:00 – 12:30 pm	Clearance: Launch and After Tony Blank, Infinity Biomedical Group What clearance does and does not mean Promotional practices for 510(k) devices FDA FTC Complaint Handling and MDRs
12:30 – 1:30 pm	Networking Lunch
1:30 – 2:00 pm	When to File a New 510(k) for Device Modifications Tony Blank, Infinity Biomedical Group Catch-up 510(k)s
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 Sergio de del Castillo, FDA Definition of a De Novo When De Novo is used Differentiation from 510(k) Format Use of pre-sub Post market requirements Use as a predicate
3:45 – 4:30 pm	Regulatory Strategy for De Novo Holly Drake, Dexcom Key eligibility criteria Benefit-risk analysis Case example
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!

Search form

You are here

510(k) Submissions Workshop - Spring 2020