The Pre-Submission Program 

and Meetings with FDA Staff

LCDR Kimberly Piermatteo, MHA

Consumer Safety Officer

Center for Devices and Radiological Health

U.S. Food and Drug Administration
Learning Objectives

1. To understand what is a Q-Submission

2. To understand the various types of requests for FDA 

feedback that are tracked as Q-Submissions

3. To provide an overview of the recommended 

information which should be submitted in these 

requests

4. To understand when certain feedback requests are 

appropriate and when they are not 2
Presentation Outline

• Q-Submissions

• Pre-Submissions

• Informational Meetings

• Study Risk Determinations

• Formal Early Collaboration Meetings

• Submission Issue Meetings

• Day 100 Meetings for PMA Applications

3
Presentation Outline

• Q-Submissions

• Pre-Submissions

• Informational Meetings

• Study Risk Determinations

• Formal Early Collaboration Meetings

• Submission Issue Meetings

• Day 100 Meetings for PMA Applications

4
5

http://www.fda.gov/downlo

ads/MedicalDevices/Devic

eRegulationandGuidance/

GuidanceDocuments/UC

M311176.pdf
Q-Submissions

• Feedback mechanisms addressed in guidance:

– Pre-Submissions

– Informational Meetings

– Study Risk Determinations

– Formal Early Collaboration Meetings

– Submission Issue Meetings

– Day 100 Meetings for PMA Applicants

• Organizational Structure: Q-Submissions or Q-Subs

6
Tracking a Q-Sub

Requests will be assigned unique identification number 

(e.g. Q150001)

– Supplements (Q150001/S001)

– Amendments (Q150001/A001)

7
Submitting a Q-Sub

• Two copies are required (One copy must be an electronic copy or eCopy)

• Requests must be submitted through the Document Control Center (DCC) 

• Address for Q-Subs:

U.S. Food and Drug Administration

Center for Devices and Radiological Health

Document Control Center (DCC) – WO66-G609

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

• Q-Sub applicants will receive an acknowledgement letter that contains the Q 

number

• For a subset of Q-Subs, an acceptance review will be conducted within 14 days 

of receipt of the Q-Sub (e.g. Pre-Submissions, Informational Meeting requests 

and Submission Issue Meeting requests) 8
Q-Sub Reminders 

• Clearly identify the desired mechanism for feedback

• Submissions should be in English

• Be clear and concise

• Must submit an eCopy

• Feedback requests are confidential and subject to 

disclosure review pursuant of the Freedom of 

Information Act (FOIA)

9
Q-Sub Reminders – Meeting Requests

• Various factors affect the scheduling of meetings

• Teleconferences are encouraged, whenever possible and 

appropriate

• Complete background information should be provided at the 

time of the initial request

• For meeting duration requests longer than 1 hour a rationale 

should be provided

10
Q-Sub Reminders – Meeting Requests 

Continued

• Foreign Meeting Attendees

• Meeting slides should be provided electronically at least two 

business days before the scheduled meeting

• Attendees should arrive 30 minutes before the scheduled 

meeting

• No audio or video taping is permitted

• Meeting minutes should be taken and submitted within 15 

calendar days of the meeting 11
Presentation Outline

• Q-Submissions

• Pre-Submissions

• Informational Meetings

• Study Risk Determinations

• Formal Early Collaboration Meetings

• Submission Issue Meetings

• Day 100 Meetings for PMA Applications

12
Q-Sub Type: Pre-Submissions

• A formal written request for feedback from FDA to help 

guide product development and/or application preparation

• Voluntary program

• No user fees

• Feedback methods: in-person meeting, teleconference, 

facsimile or email

• Timeframe: 75-90 days (*21 days for urgent public health issues)

13
Recommended Information for Pre-Sub Packages

• Cover Letter 

• CDRH Premarket Review Submission Cover Sheet (Form FDA 3514)

• Table of Contents

• Detailed Device Description

• Proposed Intended Use/Indications for Use

• Summary of Previous Discussions or Submissions Regarding the Same Device

• Overview of Product Development 

• Specific Questions for FDA Feedback

• Preferred method to receive FDA Feedback

• Meeting Format, Preferred Dates and Times, Planned Attendees, and 

Audiovisual Equipment Needs, if meeting or teleconference is requested 14
Examples of Appropriate Pre-Sub Questions

• Are the proposed trial design and selected control group appropriate?

• Does the FDA concur with the use of the proposed alternative test 

method, which is different than the normally recognized standard?

• Is a “moderate level of concern” the appropriate level of concern for my 

software?

• Are there concerns with the predicate device proposed?

• What specific information about a postapproval study should the PMA 

contain?

• Are the proposed study designs for demonstrating precision and 

accuracy adequate to support use of the assay in the Phase 3 clinical 

study? 15
A Pre-Sub is Not For...

• Requests for general information or questions

• FDA to design study protocols or clinical trial design for applicants

• Substitute for conducting your own research and analysis of current 

medical device development practices

• Addressing questions that a reviewer could readily answer

• The interactive review of an active submission 

• An appeal regarding a decision on a premarket submission

• Requests for jurisdictional designation (RFD)

• Requests for device classification (Section 513(g)) 

• Other mechanisms of feedback addressed later in this presentation 16
Pre-Sub Reminders

• A Pre-Sub is not meant to be iterative

• FDA review of a Pre-Sub does not guarantee 

approval or clearance of future premarket 

applications 

• FDA intends to stand behind their feedback

• Sponsors should reference Pre-Sub feedback 

received in subsequent submissions 17
Presentation Outline

• Q-Submissions

• Pre-Submissions

• Informational Meetings

• Study Risk Determinations

• Formal Early Collaboration Meetings

• Submission Issue Meetings

• Day 100 Meetings for PMA Applications

18
Q-Sub Type: Informational Meetings

• A meeting with the intent to share information with FDA without 

the expectation of receiving feedback

• FDA is in listening mode

• Timeframe: 90 days, resource permitting

• An Informational Meeting may be appropriate: 

– Provide an overview of ongoing device development

– Familiarize reviewers about new device with significant 

differences in technology from currently available devices 

19
Recommended Information for an 

Informational Meeting Request

• Cover Letter

• CDRH Premarket Review Submission Cover Sheet

• Brief Statement 

• Proposed Agenda

• Preferred Meeting Format

• Preferred Dates and Times (minimum of three)

• Planned Attendees

• Audiovisual Equipment Needs, if any 20
Presentation Outline

• Q-Submissions

• Pre-Submissions

• Informational Meetings

• Study Risk Determinations

• Formal Early Collaboration Meetings

• Submission Issue Meetings

• Day 100 Meetings for PMA Applications

21
Q-Sub Type: Study Risk Determinations

• FDA will help sponsors, clinical investigators, or 

institutional review boards (IRB) make a study risk 

determination for not exempt studies

• FDA will provide a study determination letter 

• FDA’s determination is final

• No obligation to submit IDE

22
Recommended Information for a Study Risk 

Determination

• Cover Letter

• CDRH Premarket Review Submission Cover Sheet

• Detailed Device Description

• Study Protocol

• Description of how the device will be used

• Description of the population

• Sponsor’s name and contact person(s), including titles, address, 

phone number, fax number and email address 23
Q-Sub Type: Study Risk Determination

Information Sheet Guidance for IRBs, Clinical Investigators, 

and Sponsors – Significant Risk and Nonsignificant Risk 

Medical Device Studies 

(http://www.fda.gov/downloads/RegulatoryInformation/Guidanc

es/UCM126418.pdf) 

24
Presentation Outline

• Q-Submissions

• Pre-Submissions

• Informational Meetings

• Study Risk Determinations

• Formal Early Collaboration Meetings

• Submission Issue Meetings

• Day 100 Meetings for PMA Applications

25
Q-Sub Type: Formal Early Collaboration 

Meetings

• Specifically outlined in the FD&C Act, as amended by FDA Modernization 

Act of 1997 (FDAMA) (Public Law 105-115)

• Two types:

– Determination Meetings (as described in section 513(a)(3)(D) of the 

FD&C Act) 

– Agreements Meetings (as described in section 520(g)(7) of the FD&C 

Act)

• Determination and Agreement Meetings are for specific purposes as 

described in the FD&C Act 

26
Q-Sub Type: Formal Early Collaboration 

Meetings

Guidance - Early Collaboration Meetings Under the FDA 

Modernization Act (FDAMA) 

(http://www.fda.gov/MedicalDevices/DeviceRegulationandG

uidance/GuidanceDocuments/ucm073604.htm)

27
Presentation Outline

• Q-Submissions

• Pre-Submissions

• Informational Meetings

• Study Risk Determinations

• Formal Early Collaboration Meetings

• Submission Issue Meetings

• Day 100 Meetings for PMA Applications

28
Q-Sub Type: Submission Issue 

Meetings

• To discuss deficiencies identified during the review 

of a premarket application, including associated 

amendments or supplements

• Timeframe: 21 days

29
Recommended Information for a Submission 

Issue Meeting Request

• Cover Letter

• CDRH Premarket Review Submission Cover Sheet

• Reference to Premarket Submission Number 

• Brief Statement (including purpose, scope, or objectives of meeting)

• Proposed Agenda Including Deficiencies for Discussion

• Focused Questions

• Preferred Meeting Format

• Preferred Dates and Times (minimum of three)

• Planned Attendees

• Audiovisual Equipment Needs, if any 30
A Submission Issue Meeting Request is Not:

• For briefly clarifying questions that can be readily 

addressed by the lead reviewer

• For FDA feedback on a proposed protocol prior to 

conducting a major study to address a deficiency 

• For the pre-review of planned responses

• Interactive review

31
Presentation Outline

• Q-Submissions

• Pre-Submissions

• Informational Meetings

• Study Risk Determinations

• Formal Early Collaboration Meetings

• Submission Issue Meetings

• Day 100 Meetings for PMA Applications

32
Q-Sub Type: Day 100 Meetings for PMA 

Applications

• Meeting to discuss the review status of an applicant’s PMA 

application

• Subset of Submission Issue Meetings

• Day 100 Meeting requests should be made in the original 

PMA or as a Q-Sub within 70 days of the PMA filing date

33
Recommended Information for a Day 100 

Meeting Request

• Preferred Meeting Format

• Planned Attendees

• Preferred Dates and Times 

• Guidance on PMA Interactive Procedures for Day-100 Meetings 

and Subsequent Deficiencies – for Use by CDRH and Industry 

(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance

/GuidanceDocuments/ucm080190.htm) 

34
Day 100 Meeting Reminders

• Pre-defined meeting

• If the request is made after the original PMA is submitted, a 

written request should be submitted

• FDA and the applicant may mutually consent to establish a 

different time for the Day 100 Meeting

• FDA will identify deficiencies within 90 days from the filing 

date of the PMA or 10 days prior to any Day 100 Meeting

35
Summary

1. Q-Submissions or Q-Subs are used to track various 

mechanisms for requesting FDA feedback. 

2. There are six types of feedback requests tracked as QSubs. 

3. The recommended information to be provided in a 

feedback request is specified by the Q-Sub type.

4. Questions and/or situations when a feedback request is 

appropriate depends on the type of Q-Sub. 

36
References

• Requests for Feedback on Medical Device Submissions: The PreSubmission Program and Meetings with Food and Drug Administration 

Staff: 

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGu

idance/GuidanceDocuments/UCM311176.pdf

• MDUFA III Commitment Letter: 

http://www.fda.gov/downloads/MedicalDevices/NewsEvents/Workshops

Conferences/UCM295454.pdf

• eCopy Program for Medical Device Submissions: 

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGu

idance/GuidanceDocuments/UCM313794.pdf 37
References

• CDRH Premarket Review Submission Cover Sheet (Form FDA 3514): 

http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/

UCM080872.pdf

• Types of Communication During the Review of Medical Device 

Submissions - Guidance for Industry and Food and Drug Administration 

Staff: 

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Guid

anceDocuments/ucm341918.htm

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39

Industry Education Resources

Three Resources

1. CDRH Learn – Multi-Media Industry Education

 over 80 modules

 videos, audio recordings, power point presentations, software-based “how to” modules

 mobile-friendly: access CDRH Learn on your portable devices (http://www.fda.gov/Training/CDRHLearn)

2. Device Advice – Text-Based Education

 comprehensive regulatory information on premarket and postmarket topics 

(www.fda.gov/MedicalDevices/DeviceRegulationandGuidance)

3. Division of Industry and Consumer Education (DICE)

 Contact DICE if you have a question

 Email: DICE@fda.hhs.gov

 Phone: 1(800) 638-2014 or (301) 796-7100 (Hours: 9 am-12:30 pm; 1 pm-4:30pm EST)

 Web: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ContactUs-- DivisionofIndustryandConsumerEducation/default.htm
Thank You

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