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Q-Submission Program for Medical 

Device Submissions

Susannah Gilbert

Acting Policy Analyst 

Division of Submission Support

Office of Regulatory Programs

Center for Devices and Radiological Health

June 11, 2019
3

• Objectives

• Background 

• Q-Submission Program and Scope of Guidance 

• Types of Q-Submissions

• Significant Changes in Q-Submission Guidance

• Resources and Questions

Agenda
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• Q-Submission: Mechanism to request different types of interactions with 

the FDA 

• Premarket Approval Application (PMA): Mechanism to request approval 

for a class III medical device

• Investigational Device Exemption (IDE): Mechanism to request 

approval for a significant risk clinical study of an unapproved device or 

unapproved use of a device

• Investigational New Drug (IND): Mechanism to request a drug or 

biological drug be used in a clinical investigation

Definitions
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Objectives

• Provide an overview of the scope of the Q-Submission Program 

described in the FDA’s Guidance Document Requests for Feedback and 

Meetings for Medical Device Submissions: The Q-Submission Program

published May 7, 2019

• Provide an overview of the different mechanisms available to request 

feedback from or interactions with the FDA

• Review significant changes made in this Guidance Document
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Background

1995

Pre-IDE Program

• Mechanism to obtain FDA feedback on future IDEs

2013

Pre-Submission Program

• Pre-IDE submissions + feedback requests prior to other marketing submissions (e.g. PrePMAs, Pre-510(k)s)

2019

Q-Submission Program

• Pre-Submissions + other requests for FDA interaction 
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Q-Submission Program

The Q-Submission Program provides a mechanism

to request interactions with the FDA related to 

medical device submissions

• Different topics for interactions

• Different types of feedback

 Many different types of Q-Submissions
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• Identifies and describes different Q-Submission types

• Identifies submission types covered in other guidance documents and 

tracked as Q-Submissions

• Identifies submission types outside the scope of the Q-Submission 

Program

• Outlines Q-Submission Processes

Scope of Guidance Document
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Q-Submission Types

Pre-Submission 

Written 

Feedback

Pre-Submission

Meeting 

Requests

Informational 

Meetings

Study Risk 

Determinations

Submission 

Issue Requests

PMA Day 100 

Meetings

Early 

Collaboration 

Meetings

Accessory 

Classification 

Requests

Breakthrough 

Device Designation 

Requests

Interaction for 

Breakthrough 

Devices
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Pre-Submissions 

• Specific questions

• Recommend 3-4 substantial topics 

• Help guide product development, develop protocols, prepare 

premarket applications

Requests for feedback from the FDA regarding 

future premarket submissions, Accessory 

Classification Requests, or CLIA Waivers

Pre-Submission 

Meeting

Pre-Submission 

Written Feedback
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Pre-Submission MDUFA IV Commitments

• MDUFA IV commitments included in Guidance Document:

• Goal feedback timelines 

• Applicants responsible for draft minutes

• New Pre-Submission Acceptance Checklist (RTA)

• Example questions leading to productive interactions

• Appendix 2 (page 27)

• Consistency in provided feedback

Pre-Submissions are the only Q-Submission 

with MDUFA IV commitments and goals
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Submission Issue Requests

• Request written feedback or a meeting

• Discuss approach to address deficiencies in formal response 

• Help move project forward 

Requests to discuss outstanding review issues 

that were provided in a marketing submission 

hold letter, IDE letter, or IND Clinical Hold letter
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Study Risk Determinations

• FDA provide final decision in writing 

• Risk determination for proposed clinical study defined in CFR 

812

• 4 possible final determinations:

Requests for a risk determination for proposed 

clinical study

Significant Risk Non-Significant Risk Exempt Basic Physiological Research
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Informational Meetings

• No official feedback

• Interactive dialogue 

• Topics can include:

• Device development

• New technologies

• Topics outside the scope of other Q-Submissions

Meeting intended to share information with the FDA
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• Interactions tracked as Q-Submissions that have specific 

policy and procedures described in other FDA Guidance 

Documents:

• PMA Day 100 Meetings

• Breakthrough Device Requests and Interactions

• Early Collaboration Meetings

• Accessory Requests

• Lower volume of requests

Other Q-Submission Types
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Included MDUFA IV Commitments for Pre-Submissions:

• RTA timeframe 

• Meeting scheduling logistics

• Written feedback timing 

To support these goals we have developed 2 type of 

Pre-Submissions: 

Significant Changes from 

Pre-Submission Guidance

RTA Meeting 

Scheduled

Written Feedback 

Due Performance Goal

Pre-Submission 

Meeting By Day 15 By Day 30

5 Days before meeting 

or Day 70 – whichever 

is sooner

• Meeting Set Date 

• Written Feedback 

Date

Pre-Submission 

Written Feedback By Day 15 N/A Day 70 • Written Feedback 

Date
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Time between when associated letter was sent 

and Submission Issue Request was received Goal Review Time 

i. ≤ 60 days 21 Days

ii. > 60 days 70 Days

Acceptance Review (RTA):

• Pre-Submission RTA streamlined 

• Submission Issue Request & Informational Meeting RTA removed

Submission Issues Requests 

• Naming: 

• Submission Issue Meetings  Submission Issue Requests

• Requested Feedback: 

• Written Feedback OR Meeting 

• 2 Tiered Review Timeline: 

Significant Changes from 

Pre-Submission Guidance
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• Many Q-Submission types all providing a mechanism to request FDA interaction 

• Each has its own review process and timelines 

• New FDA Guidance Document:

• Describes Q-Submission types and timelines 

• Provides resources for the Q-Submission types with policy and procedures 

described in other FDA Guidance Documents 

• All Q-Submissions follow the same general processes regarding:

• Formal submissions to the Document Control Center (DCC)

• eCopy (electronic copy) requirements

• Tracking with original Q-Submissions, supplements, & amendments

• Meeting formats and submission of meeting minutes

Summary
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• Q-Submission Program Final Guidance

• Breakthrough Device Program Guidance Document

• PMA 100 Day Meeting Guidance Document

• Early Collaboration Meeting Guidance Document

• Medical Device Accessories Guidance Document

• eCopy Program for Medical Device Submissions

Resources
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Questions?

Division of Industry and Consumer Education: 

DICE@fda.hhs.gov

Office of Regulatory Programs, Division 1: Division of 

Submission Support: 

CDRHPremarketProgramOperations@fda.hhs.gov

Slide Presentation, Transcript and Webinar Recording will be 

available at:

http://www.fda.gov/training/cdrhlearn: Under the “How to 

Study and Market Your Device” section; Subsection: “PreSubmissions”