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510(k) Submissions Workshop - Spring 2020

February 24, 2020 to February 25, 2020
Irvine, CA
Regulatory
Workshop

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
Hogan Lovells (Invited)

  • 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)
Hogan Lovells (Invited)

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
FDA (Invited)

  • 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

Post-Clearance Exercise

2:30 – 2:45 pm

Break

2:45 – 3:45 pm

De Novo
FDA (Invited)

  • 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

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!