FDA Presubmission Program – Requesting FDA Feedback


Course Overview

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.

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Additional Recommended Courses

Design Controls for Medical Devices and IVDs

This virtual instructor-led two-day course covers design control principles and design and development regulatory requirements relative to U.S. 21 CFR Part 820, ISO 13485:2016 and the EU MDR. Practical examples will be incorporated.

This course covers important requirements for medical device and IVD design controls. Learners will benefit from open dialogue and the sharing of current design and development principles, including the interrelationship of risk management and design and development throughout the lifecycle of a device.  This course includes interactive group activities relative to all phases of design and development.

Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

By the end of this training you should be able to:

  • Identify key regulatory requirements for risk management
    • European Union
    • Quality System Regulation
    • ISO 13485:2016
  • Identify key principles of ISO 14971:2019
  • Identify key regulatory requirements for design controls:
    • European Union
    • Quality System Regulation
    • ISO 13485:2016
  • Recognize potential exemptions from design control requirements
  • Identify when, during a design and development project, design control requirements apply
  • Conceptualize graphically a design control process

Who Should Attend

This class is vital for any medical device research and development professional, regulatory scientist, and/or clinician involved in developing and manufacturing medical devices. This course provides critical knowledge for both regulatory affairs and quality assurance professionals.

Price: $1200.00