The pre-submission or Q-Sub program is a voluntary mechanism to get FDA’s feedback on specific questions necessary to guide product development and/or application preparation. This course provides instruction critical to prepare for a successful meeting with the FDA.
By 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 certificate Medical Device Certificate
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