FDA Presubmission Program – Requesting FDA Feedback

The U.S. Food and Drug Administration’s pre-submission or Q-Sub Program is a voluntary mechanism to get FDA feedback on specific questions necessary to guide product development and/or application preparation. This two-hour course provides instruction critical to prepare for a successful meeting with the FDA.

The FDA strongly encourages seeking feedback, but the process can be confusing and it’s important to be prepared when you get your FDA meeting. This course was developed by a recent FDA insider and provides an overview of the mechanisms to request feedback from the FDA regarding 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) Waivers by Application and certain Investigational New Drug Applications (INDs) and Biologics License Applications (BLAs).

The course covers logistics for submission, receipt, tracking and review of or response to these requests. The feedback mechanisms include pre-submissions, informational meetings, study risk determinations, formal early collaboration meetings (such as agreement and determination meetings), submission issue meetings and PMA Day 100 meetings.

At the end of this module, you will be able to:

• Define Q-Submissions and the Q-Submission Program
• Recognize when to utilize the program’s mechanisms to get FDA feedback
• Identify how to apply the guidelines from FDA guidance documents
• Prepare a quality Q-Submission that effectively and efficiently conveys the information needed for prescriptive feedback
• Identify common mistakes in a Q-Submission
• Engage in a productive discussion with FDA during a face-to-face or teleconference meeting

By completing/passing this course, you will attain the Medical Device Certificate.