Chicago Chapter: Requesting Feedback - FDA’s Presubmission Process

When:  Jan 24, 2019 from 5:30 PM to 8:30 PM

Thursday, 24 January 2019
5:30-8:30 pm CST
AbbVie One
26525 North Riverwoods Road
First Floor, São Paulo Conference Room
Mettawa, IL 60045-3440
+1 800 255 5162

Join local regulatory professionals for a presentation on the Food and Drug Administration’s (FDA) Presubmission Process.

The mechanisms applicants can use to request feedback from FDA about potential or planned medical device Investigational Device Exemption (IDE) applications or other premarket submissions, such as Premarket Approval (PMA) applications, Humanitarian Device Exemption (HDE) applications, Evaluation of Automatic Class III Designations (De Novo requests), Premarket Notification (510(k)) Submissions, Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application and certain Investigational New Drug Applications (INDs) and Biologics License Applications (BLAs) will be reviewed.

The logistics for submission, receipt, tracking and review of/response to these requests also will be discussed.

In addition, there will be information on feedback mechanisms, including Pre-Submissions, Informational Meetings, Study Risk Determinations, Formal Early Collaboration Meetings (i.e., Agreement and Determination Meetings), Submission Issue Meetings and PMA Day 100 Meetings.

These feedback requests are collectively referred to as “Q-Submissions” or “Q-Subs.” FDA believes the Q-Sub structure provides a convenient and effective way to track them.

This program is brought to you by the RAPS Chicago chapter and is intended to promote knowledge sharing and engagement with others in the local regulatory community. Dinner will be provided and RAC holders may claim three RAC recertification credits.

Featured Speaker:
Deborah Baker-Janis, RAC, MS, senior director, NSF Medical Devices

Registration Information:
RAPS Members: $30
Nonmembers:  $45



26525 N Riverwoods Blvd
Mettawa, IL 60045-3440