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IDE Submissions Workshop - Spring 2020

February 26, 2020
Irvine, CA

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!

View the full agenda

Download the full agenda

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?
Doug Dumont, FDA

  • The purpose of an IDE exemption
  • Different types of IDEs
  • What an IDE does (and does not) permit
  • When manufacturers or physicians should seek an IDE
  • Roles of IRBs, investigators, and sponsors

9:45 – 10:00 am

Break

10:00 – 11:30 am

Preparing the Technical & Functional Aspects of an IDE
Pam Weagraff, IQVIA

  • Elements of an IDE: Intro/Background, Manufacturing/Device, Labeling, Reference/Other
  • Avoiding common errors and deficiencies
  • The role of risk analysis in an IDE
  • Managing planned or unplanned device or study changes

11:30 – 12:15 pm

Regulatory Compliance During Study Conduct
Gerry Prud'homme, Hogan Lovells

  • Monitoring
  • Consenting of patients
  • Enrollment requirements
  • Adverse event reporting
  • Sponsor records and reports
  • Investigator records and reports
  • Protocol deviations

12:15 – 1:15

Networking Lunch

1:15 – 2:00 pm

Reporting Results
Pam Weagraff, IQVIA

  • Clinical study reports (interim and final)
  • Dissemination to the medical community and to regulators
  • Incorporation into pre-market submissions
  • Assessment of impact to product labeling
  • Requirements for registering trials on CT.gov

2:00 – 2:45 pm

Optimizing the Pre-PMA Meeting
Gerry Prud'homme, Hogan Lovells

  • Purpose and value of the meeting
  • Requesting a Pre-PMA meeting
  • Identifying discussion questions
  • Team preparation and rehearsals

2:45 – 3:00 pm

Break

3:00 – 3:45 pm 

Developing an IDE Strategy
Tony Blank, Infinity Biomedical Group

  • What to consider and when
  • Preclinical testing before human studies
  • Making the best use of pre-submission meetings
  • Using foreign data in a US submission
  • Characteristics of a successful IDE submission

3:45 – 4:45 pm

BIMO Audits
Albert Rodriguez, FDA

  • The purpose of a BIMO inspection
  • When and how a BIMO inspection occurs
  • Preventing findings and responding to findings
  • Typical and atypical observations – cautionary tales from the field

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!