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mechanism by which it is supported. Information is provided on the sub-
mission pathway for regulatory authorities in the European Union (EU)
and the United States.

9.2 Seeking FDA feedback

In 2019, the FDA published the guidance document “Requests for Feedback
and Meetings for Medical Device Submissions: The Q-Submission
Program—Guidance for Industry and Food and Drug Administration
Staff.” This guidance is intended to provide a summary of the pathways
available to industry for early collaboration and discussions about medical
device submissions with the Center for Devices and Radiological Health
(CDRH) and the Center for Biologics Evaluation and Research (CBER).
It is available at: https://www.fda.gov/downloads/medicaldevices/device-
regulationandguidance/guidancedocuments/ucm311176.pdf.
This guidance document presents the methods through which industry can
request feedback from or a meeting with the FDA via Q-Submissions or Q-Subs.
Q-Subs can be related to various types of premarket submissions such as:
• Investigational Device Exemption (IDE) applications,
• Premarket Approval (PMA) applications,
• Humanitarian Device Exemption (HDE) applications,
• Premarket Notification [510(k)] Submissions,
• Clinical Laboratory Improvement Amendments (CLIA) Waiver by
Applications (CW),
• Dual 510(k) and CLIA Waiver by Application Submissions (Duals),
• Accessory Classification Requests, and
• certain Investigational New Drug Applications (INDs) and Biologics
License Applications (BLAs).
Q-Subs are requests for interaction with FDA regarding potential or
planned medical device submissions, potential or planned device-led com-
bination product submissions, as well as issues communicated in mar-
keting submission hold letters, Investigational Device Evaluation (IDE)
letters, Clinical Laboratory Improvement Amendments (CLIA) Waiver by
Applications (CW) hold letters, and certain Investigational New Drug
(IND) Clinical Hold letters.
There are several different types of Q-Subs that provide mechanisms
to request FDA interaction and which are discussed in this guidance doc-
ument. Some of these include Pre-Submissions, Informational Meetings,
Study Risk Determinations, and Submission Issue Requests.