1. US FDA Pre-Submissions (Q Subs)
BioUtah Pre-Submissions Workshop
6 April, 2016
Phil Triolo, PhD RAC
President, Phil Triolo and Associates LC
1. GOOD MORNING OR AFTERNOON
I’VE BEEN A MEMBER OF THE SURFACES IN BIOMATERIALS FOUNDATION FOR 12 YEARS AND THE EDITOR OF THE REGULATORY SECTION OF SURFACTS, THE FOUNDATIONS’ QUARTERLY NEWSLETTER, FOR THE PAST 3 YEARS. I’M GOING TO SHAMELESSLY PLUG THE ORGANIZATION, BECAUSE I’VE FOUND THE MEETINGS AND THE INFORMATION PROVIDED AT THE MEETINGS TO BE THE MOST USEFUL AND PRACTICAL MATERIALS INFORMATION AVAILABLE. THE ORGANIZTION HAS AN INDUSTRIAL RATHER THAN ACADEMIC LEANING.CONSEQUENTLY THE PRESENTATIONS AND MATERIALS, SURFACE MODIFICATIONS, AND COATINGS DISCUSSED ARE NOT THEORETICAL IN NATURE. THE PRODUCTS AND SERVICES DESCRIBED ARE RELEVANT AND CAN MEET CURRENT NEEDS FOR DEVICES AND MATERIALS WITH TAYLORED SURFACE FEATURES.
OK ENOUGH OF THAT. JUST JOIN- MEMBERSHIP IS A REAL BARGAIN.
TODAY I’M GOING TO DISCUSS HOW TO ASSESS THE BIOLOGICAL SAFETY OF A NEW MEDICAL DEVICE. NOTE THAT DEVICES ARE SUBJECT TO EVALUATION, NOT MATERIALS. MATERIALS ARE, IN GENERAL APPROVED FOR USE IN DEVICES (EXCEPTIONS ARE SUTURE AND CONTACT LENS MATERIALS, AND COLORANTS MADE SPECIFICALLY FOR THESE APPLICATIONS.)
AN ASSESSMENT OF BIOLOGICAL RISKS OR EFFECTS IS REQUIRED IN ORDER TO MARKET A MEDICAL DEVICE. THE STANDARDS THAT GOVERNS THE ASSESSMENT IS THE ISO SERIES OF DOCUMENTS. ISO IDENTIFIES THE BIOLOGICAL EFFECTS THAT NEED TO BE ASSESSED. THE FDA DOESN’T FULLY ACCEPT THE EFFECTS IDENTIFIED IN ISO AND HAS PROVIDED A TABLE WITH ADDITIONAL TEST CONSIDERATIONS IN TABLE 1 OF MEMO G95-1. I WON’T DISCUSS JAPANESE BIOCOMPATIBILITY REQUIREMENTS. THESE ARE IDENTIFIED IN JAPANESE MINISTRY OF HEALTH AND WELFARE NOTICE 36.

2. Overview
Q Subs and subsequent communications with the FDA help identify regulatory submission requirements before significant resources are expended in development/ re-development efforts, especially to run clinical trials.
This presentation will provide an overview of the Pre-Submission process, when it is best employed, and identify information to provide in commonly used Q Sub types.
US FDA Pre-Submissions (Q Subs) © 2016 Phil Triolo April, 2016

3. Overview
Note that FDA approaches are not always consistent, so that although the strategies and information presented in this presentation may have been effective/ valid in the past, they may not be in the future. (general disclaimer)
US FDA Pre-Submissions (Q Subs) © 2016 Phil Triolo April, 2016

4. Relevance- Manufacturer Concerns
The definitions and regulations published by the FDA are often open to interpretation. Additionally, some classifications and regulatory decisions are based on precedent or specific regulations, and the precedent or regulation may not be known to a new medical device manufacturer or manufacturer of a new medical device. Clarification is often needed to determine regulatory requirements, which dictate the resource requirements for bringing a new medical product to market. Financial backers (venture capitalists, funding agencies) oftentimes will not provide funds until the manufacturer can assure that the regulatory pathway will not be unreasonably burdensome (i.e., resource intensive).
US FDA Pre-Submissions (Q Subs) © 2016 Phil Triolo April, 2016

5. FDA Feedback
Manufacturers have several options for obtaining Agency feedback on the categorization of their product and, if a device, its classification (Class I, II, II) and marketing application (510k, PMA, de novo) requirements. RFDs (Requests For Designation) are used to determine if the product is a drug, device, biologic, or combination product; and, if a combo, the Center with primary jurisdiction over premarket review. 513(g)s (Requests for Information) are used to classify a device and are typically used to determine if a 510k can be submitted, which requires the identification of a suitable predicate device. 513(g)s can also be used to help determine the type of information (clinical, non-clinical) that will be required, and standards and guidance documents that are applicable.
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6. Q Subs
Pre-subs are typically used to ask specific questions about premarket submissions, including IDE’s, premarket verification and validation test plans, NSR vs SR determinations, and other issues. Pre-sub meetings are highly recommended, as they focus activities and force the early creation of regulatory documents that will be used, in their final forms, in regulatory submissions.
US FDA Pre-Submissions (Q Subs) © 2016 Phil Triolo April, 2016

7. Goals of Q Subs
Obtain answers to specific questions that have a significant bearing on pre-submission activities
Obtain information (and guidance) in areas that may not be specifically addressed in your Q Sub. (Yes, the FDA does comment on some items-but not all- for which you have not specifically requested feedback.)
Gain documented agreement on approaches that are presented in the Q Sub
Identify approaches that are not acceptable to the FDA so that these may be discussed and acceptable alternatives negotiated
Obtain documented FDA feedback that can be shared with investors, IRBs, and other stakeholders
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8. FDA Commitment
The 2014 guidance establishes a structured process with clear recommendations for sponsors who submit Pre-Subs, and for FDA staff and managers involved in their review, as well as expected timeframes for scheduling meetings.
FDA intends to provide the best possible advice in accordance with the information provided, ensure it is captured accurately in the meeting minutes drafted by the sponsor, and commit to that advice unless the circumstances sufficiently change such that our advice is no longer applicable, such as when a sponsor changes the intended use of their device after we provide feedback.
It is also our intention to hold timely meetings with appropriate staff and managers present, as resources permit. However, both our ability to provide advice and to hold timely meetings are dependent on our receiving the necessary information in advance of the meeting.
US FDA Pre-Submissions (Q Subs) © 2016 Phil Triolo April, 2016

9. Advantages
Time
Using the Q Sub process reduces time to regulatory approvals/ clearances (= time to market) but, the time to initially submit may be lengthened.
Preparation
Q Sub preparation forces an earlier review and documentation of product development activities than is normally exercised by smaller companies.
Documentation is produced that forces clarity and focus on product development tasks, especially pre-clinical and clinical test plans; and this documentation can be used, in its final form, in regulatory submissions.
I’ve broken down the biological safety assessment process into 6 steps. These, essentially, consist of
Identifying potential biological effects (g95-1)
Identifying the materials present in the device, the processing of those materials, and the contact they have with the patient
Id ing relevant available data for the identical materials processed by the same methods that can be used to address the potential biological effects
Performing a gap analysis to determine what additional information is needed to demonstrate an acceptable biological response
Conducting tests, documenting a toxicological risk assessment, or providing rationales to address requirements and recommendations
Preparing a final report that summarizes the information used to demonstrate an acceptable biological risk
US FDA Pre-Submissions (Q Subs) © 2016 Phil Triolo April, 2016

10. Pre Sub Caveats
The Q Sub process is specifically designed for the FDA to respond to issues and questions that a manufacturer (sponsor) raises.
FDA’s silence on a presubmission topic that was not brought up by the sponsor (for example, the selection of an endpoint in a non-clinical or clinical investigation) does not signify FDA acceptance of the sponsor’s information or position. It merely means that the FDA did not comment on that topic. (No news is not necessarily good news.)
US FDA Pre-Submissions (Q Subs) © 2016 Phil Triolo April, 2016

11. Pre-Submission (Pre-Sub) Meetings
If a sponsor is certain that its product is classified as a Class II (or III) device, but is not sure if or what type of pre-clinical and/ or clinical studies are required to establish substantial equivalence and / or a reasonable assurance of safety and efficacy:
Submit Pre-Submission (Q-Sub) Materials
FDA Guidance Document issued Feb. 18, See
for background and guidance.
See Section A of the Guidance, “When to Submit a Pre-Sub.”
Note that all pre-sub meetings had been called “Pre-IDE (investigational device exemption) Meetings.”
US FDA Pre-Submissions (Q Subs) © 2016 Phil Triolo April, 2016

12. US FDA Pre-Submissions (Q Subs) © 2016 Phil Triolo 6 April, 2016

13. Who may submit a Q Sub?
Q Subs are for entities that are planning a medical device submission to the FDA. They are not for research organizations, advocacy groups, or others who do not intend to market a device in the US.
US FDA Pre-Submissions (Q Subs) © 2016 Phil Triolo April, 2016

14. Q Sub Logistics
Submit One (1) eCopy and One (1) hard copy to the Document Control Center (DCC). Address:
U.S. Food and Drug Administration
Center for Devices and Radiological Health
Document Control Center –WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD
(Ryan O’Callaghan will address eCopy requirements.)
US FDA Pre-Submissions (Q Subs) © 2016 Phil Triolo April, 2016

15. Q Sub Logistics
FDA sequentially assigns the Pre Sub a Q Sub Number (QYYxxxx)
Q Subs are Amended or Supplemented
Amendments contain additional information about an existing request for feedback, for example: Slides, Agenda updates, Meeting minutes, Meeting minutes disagreements
Supplements contain NEW requests for feedback on the same device/
indication, for example:
Original request for feedback on planned bench testing
S001 request for feedback on clinical plan
S002 request for feedback on a different or significantly revised clinical plan
New Q-Sub numbers are assigned for subsequent requests for feedback if
The device and/or indications for use have changed significantly
The Q Sub Type changes
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16. Q Sub Contents Cover Letter Table of Contents CDRH Cover Sheet
RTA (Refuse to Accept) Checklist
Device Information
Q-Sub Specific Information (See below.)
Questions
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17. Q Sub Contents-Cover Letter
Inside Address:
For CDRH submissions, the addressee may be the appropriate branch or branch chief if the applicant knows where the subject device or similar devices are reviewed.
For CBER submissions, the addressee may be the appropriate Office Director or Regulatory Project Manager where the subject device or similar devices are reviewed.
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18. Cover Letter
Contents
Clearly stated reason for the submission in the reference line (e.g., Pre-Sub for a 510(k), Pre-Sub for an IDE, Pre-Sub for an IND or BLA)
Device Name
Information specific to the Q-Sub type, if applicable- A general overview
Previous Discussions or Submissions
Method for Feedback
Specific Questions
Sponsor contact information
Signature of the contact person, or other responsible party
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19. Table of Contents
FDA: To facilitate ease of review, please include a table of contents at the beginning of your Pre-Sub showing items and page numbers. We strongly recommend the use of tabs or dividers, where appropriate, between sections, and sequential numbering of the pages of your hard copy Pre-Sub package. Electronic copies should follow the formatting requirements as outlined in the eCopy guidance referenced in Section III. “Submitting a Q-Sub” above.
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20. CDRH Cover Sheet
Form 3514, CDRH Cover Sheet, indicating that the submission is a Pre Sub
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21. Refuse to Accept (RTA) Checklist
The acceptance (=Refuse To Accept) checklist clearly outlines how FDA determines if a Q-Sub meets the definition of the identified Q-Sub type, and how it determines if a qualifying request is administratively complete.
It is not necessary for each element in the checklist to be present for the submission to be accepted. Instead, the acceptance checklist is intended to ensure only that the submission includes sufficient information for FDA to provide the requested feedback and/or identify the appropriate FDA attendees so that the meeting or teleconference can be scheduled.
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22. Device Information Contents Device Description
Proposed Intended Use/ Indications for Use
Overview of Product Development
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23. Content Specific to the Q Sub Type (510k, PMA, IDE, etc.)
See FDA Guidance, Appendix 1, as well as this presentation.
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24. Details: Method for Feedback
Options+:
In-person meeting
Teleconference
Facsimile, or
E mail
+Please note that FDA will ultimately decide the means of communicating the feedback, but will consider the desired method requested in the Pre-Sub.
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25. FDA Feedback to Q Sub
FDA feedback to a Pre-Sub can be provided in multiple ways, including through an in-person meeting, a teleconference, facsimile18 or by .19 If FDA feedback will be through a meeting or teleconference, at least 3 business days prior to the meeting, FDA will provide initial feedback to the applicant by , which should include: written responses to the applicant’s questions (in reality, responses are often provided 1 or 2 days prior to the meeting); FDA’s suggestions for additional topics for the meeting or teleconference, if applicable; or, a combination of both. Ask for telecon or in-person meeting, so you can discuss the ed responses. This allows you to establish a rapport with the reviewer and, hopefully… your credibility. You will also gain insight on the issues raised by the Agency, as well as its “thinking.”
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26. FDA Feedback to Pre Sub
The ed response may be a complete response to the applicant’s questions, or may consist of some initial feedback and note the need for further discussion in the meeting or teleconference.
If all of the applicant’s questions are addressed through the ed responses to the applicant’s satisfaction, FDA and the applicant can agree that a meeting or teleconference is no longer necessary and the written responses provided by will be considered the final written feedback to the Pre-Submission. FDA will aim to provide feedback to a Pre-Sub within approximately 90 days, of receipt of a complete package. (most recently: 82 days, 80 days, 37 days, and 10 MONTHS)
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27. Meeting or Teleconference Details
If you are requesting a meeting or teleconference as the method for feedback, your submission should include:
the meeting format you are requesting (i.e., in-person or by teleconference);
three (3) or more preferred dates and times when you are available to meet using the guidelines provided for response times for scheduling;
the planned attendees, including each attendee’s position, or title, and affiliation. If you have not yet identified all of your attendees, you should indicate the type of subject matter experts you plan to invite so that FDA can ensure appropriate experts are in attendance; and
a list of any audiovisual equipment you will need, such as conference phone or LCD projector.
Proposed duration (1 hour unless a longer period is justified to the FDA).
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28. FDA’s Review and Response to Q Subs
Acceptance checklist is included in Appendix 2 of guidance doc.
FDA will notify the sponsor of:
Acceptance: auto-generated notification of acceptance and name of lead reviewer
Rejection: notification that request was incomplete, including the information needed to make it complete and name of lead reviewer
Sponsor response to RTA should be submitted as amendment (Q16xxxx/A01) to DCC
Review clock begins on date of receipt of accepted submission or amendment
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29. Pre Sub Timeline Summary
Overview of the Pre-Sub Process
Sponsor submits documents to DCC
FDA conducts acceptance review (14 days)
If Meeting/telecon is requested:
FDA works with sponsor to schedule the meeting/telecon (21 days)
FDA provides preliminary feedback via (at least 3 days prior to the meeting/tcon) and meeting is held
If Meeting/tcon held:
Sponsor provides draft minutes to DCC (15 days)
FDA reviews/edits minutes (30 days)
If no meeting/telecon
FDA provides feedback ( days)
US FDA Pre-Submissions (Q Subs) © 2016 Phil Triolo April, 2016

30. How it goes So, what Probably will really happen?
You submit the Q Sub materials (probably takes 1.5 to 2 times as long as expected, because you don’t have written details of the proposed product specifications, development plan and regulatory strategy, clinical investigation plan, or other items you wish to discuss. And everyone agrees until you write something down for review…).
The FDA responds just 2 (instead of “at least 3”) days before the Q Sub Meeting (NICE!). You have 2 days to determine:
What issues/ areas you and FDA agree upon and therefore need no further discussion
What issues you need to address by either changing your approach or providing additional supporting information (Which may require a Supplement… and another 75 to 90-day review period.)
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31. Process
So you revise the Meeting Agenda and submit it to the FDA, preferably the day before the meeting, (but perhaps as late as 5 mins before the meeting starts.)
You list the items where there is agreement in the new Agenda, but propose not to discuss them.
Meeting starts: Introductions are made. (Ask for a list of FDA attendees.)
You ask if the FDA would like an overview of the product and its development (hope they say no, so they can focus on your questions- and also because this suggests that they are all familiar with your device and Q Sub contents.)
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32. Process
You provide responses to the FDA’s Q Sub feedback for discussion during the meeting.
Someone takes notes.
You summarize the conversations and FDA during the last 10 minutes of the meeting.
Meeting adjourns with requisite “thank you’s” for the feedback.
All sponsor attendees write their comments down and provide to one person (preferably the Regulatory Geek) to use to construct the minutes of the meeting.
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33. Minutes of Q Sub Meetings
Are NOT a transcript, although I’ve submitted paraphrases of the conversations, and these have been acceptable (not recommended).
Summarize the sponsor’s and FDA’s positions, indicating where there is concurrence; disagreement; and action items that remain for the sponsor and FDA (“we’ll get back to you on that…”)
There is a mechanism for disagreeing with Minutes. (See below.)
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34. Minutes From FDA Presentation:
Sponsor must submit draft minutes to DCC within 15 days
May also submit courtesy copy to lead reviewer via
Please submit on time, while the discussion is still fresh in minds
Minutes should reflect a summary of the discussion during the meeting; should not include:
A transcript
Responses to FDA’s feedback provided during the meeting [if the response was not provided during the meeting…]
(should be addressed in future submission)
Follow-up requests for feedback
(should be submitted as a Q-Sub Supplement)
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35. Minute Disagreements
FDA review team reviews and edits sponsor-written minutes, if necessary, within 30 days of receipt
If edits are needed, FDA sends revisions to sponsor via
After 15 days, FDA-edited version becomes final, unless:
Sponsor submits a “minutes disagreement amendment” to DCC identifying substantive issues with FDA’s edits
minutes disagreement should refer to disagreement regarding what was said/agreed upon during the meeting; not disagreement with the substance of FDA’s feedback
FDA will arrange a teleconference to discuss minutes
At conclusion of teleconference, FDA will revise minutes to reflect resolution OR note that the parties agree to disagree
Minutes (as revised by FDA based on telecon) are considered final
US FDA Pre-Submissions (Q Subs) © 2016 Phil Triolo April, 2016

36. Contents of Specific Q Sub Types
Pre-Submission (Pre-Sub) Meeting Guidance
Appendix - Recommendations for Specific Types of Pre-Subs
A. Pre-Sub for an IDE Application “pre-IDE meeting”
B. Pre-Sub for a NSR (Non-significant Risk), Exempt, Diagnostic Device, or OUS (Outside of US) Study (These do not require an IDE)
C. Pre-Sub for a 510(k)
D. Pre-Sub for a PMA
E. Pre-Sub for an HDE
Pre-Sub for an IVD [device]
Pre-Sub for Early Feasibility Study (EFS) IDE (talk to me…)
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37. Q Sub Contents- Study Determination (SR v NSR)
FDA Guidance: Significant Risk and Nonsignificant Risk Medical Device Studies
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38. Q Sub for Study Risk Determination
Requests FDA’s feedback on whether a planned study is a significant risk (SR) study, a non-significant risk (NSR) study, or exempt from IDE, or generally whether a planned study requires an IDE
1. Recommended Information for a Study Risk Determination Request
Please clearly indicate in your cover letter that the submission is a “Study Risk Determination” in the reference line. A request for a study risk determination should also include the following information:
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39. Q Sub for Study Risk Determination
a cover letter that clearly identifies the submission type in the reference line (i.e., a Study Risk Determination request) and, for CDRH submissions, please clearly indicate that the submission is a Study Risk Determination request on the CDRH Premarket Review Submission Cover Sheet. Use of the CDRH Premarket Review Submission Cover Sheet for submissions made to CBER is highly recommended;
a detailed description of device(s);
the protocol for the study;
a description of how the device will be used, if not included in the protocol;
a description of the population, if not included in the protocol; and
the sponsor’s name and contact person(s), including titles, address, phone number, fax number, and address.
I also include a high-level clinical hazard assessment and, when relevant, a comparison to another device/intended use whose studies were NSR.
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40. FDA Feedback on Q Sub for Study Determination
Once a determination is made, FDA will issue a letter to the sponsor indicating whether the study is exempt, or, if not exempt, is considered SR or NSR. The letter may be copied and submitted to IRB(s) with the protocol. Once FDA has made a determination, the IRB does not need to conduct an independent assessment of risk; FDA’s determination is final.
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41. Submission Issue Meetings
Appropriate for sponsor requests for:
an in-person meeting to discuss a planned approach to responding to deficiencies;
a teleconference with management participation to discuss a planned approach to responding to deficiencies; or
feedback on a planned approach to responding to deficiencies that requires in-depth preparation by the review team and management due to the nature of the questions.
For example, Sponsor requests for feedback on plans to submit a justification for not providing information requested in one or more deficiencies will likely require submission of a Q-Sub, as this type of question typically requires input from FDA management.
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42. Q Sub for a 510k
Why submit?
“The advice FDA provides prior to submission of a 510(k) may be a highly effective tool in streamlining our review and determination regarding substantial equivalence, as our advice can aid in identifying planned testing that may be unnecessary or additional testing that we will need to review in the 510(k).”
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43. Q Sub for a 510k
Timing: It is advisable to submit a Pre-Sub request for a device subject to 510(k):
prior to your initiation of critical or resource-intensive bench tests or animal or clinical studies; or
if you know clinical data will be needed to support your 510(k), but have not yet interacted with FDA about the type of data needed (and/or the most appropriate reference method for an in vitro diagnostic device), and you know the study will not require an IDE, so there will not be any other opportunity for FDA to review the protocol; or
if your planned 510(k) submission might raise unusual or atypical issues that warrant preliminary discussion with FDA.
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44. Q Sub for a 510k
Contents
Proposed Predicate Devices (Please note that FDA will not make a final determination about the suitability of a proposed predicate device until the submission and review of your 510(k). But, you may ask if they have issues with your predicate device.)
Performance Testing
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45. Q Sub for a 510k Examples of Specific Questions for a 510(k) Pre-Sub
Biocompatibility: In addition to the biocompatibility testing recommended for the type and duration of tissue contact defined by FDA’s G95-1 Bluebook Guidance and ISO , what other device-specific biocompatibility testing may be necessary to adequately evaluate the biocompatibility of my device? (Open-ended…)
Is our justification for not conducting carcinogenicity studies adequate? (Not open-ended, but yields the same response.)
ETC… (See guidance.)
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46. Q Sub for a 510k
Note that a Pre-Sub and the FDA’s response are considered “previous submissions” when submitting a 510k. The preliminary review of a 510k to determine whether or not it can be filed by FDA includes an evaluation to determine if the issues raised in Pre-Subs have been addressed in the 510(k). That is, the FDA’s Q Sub response is considered more of a “requirement” than guidance, and the preliminary RTA review of the 510k will evaluate whether or not the issues raised in FDA’s Pre-Sub response have been addressed somewhere in the notification.
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47. Q Sub for IDEs
Why?
“Receiving and incorporating FDA feedback on various elements of a future IDE submission, such as the proposed study design or statistical analysis plan, can facilitate the IDE review process and reduce the number of review cycles needed to reach full IDE approval.”
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48. Q Sub for IDEs
Timing
You may submit a Pre-Sub at any time prior to submitting your IDE. Typically, the most appropriate times to submit a Pre-Sub related to an IDE include:
prior to initiating critical animal or bench testing
(especially if the proposed testing is unusual or if the testing or study results are critical to the approval of the IDE application (e.g., an animal study intended to assess a critical safety question prior to use in human subjects)).
prior to initiating a feasibility study; or
prior to initiating a pivotal trial.
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49. Q Sub for IDEs Contents Planned Nonclinical Testing Clinical Protocol
The most common reason for submitting a Pre-Sub for an IDE is to seek advice on major elements of a clinical trial design, including:
target patient population
sample size
type of control
statistical analysis plan
study endpoints
length and type of follow-up
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50. Q Sub for IDEs Typical Questions:
Are the nonclinical study protocols (bench or animal) sufficient to allow for the collection of data from which conclusions about device safety to support initiation of a clinical study can be drawn?
Are the primary and/or secondary endpoints appropriate for the proposed indication for use?
Are the proposed trial design and selected control group appropriate?
Are the proposed sample size calculation method and related elements of the statistical analysis plan appropriate for the proposed clinical study?
Do you have any concerns about whether the proposed follow-up period is adequate for the proposed clinical study?
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51. Validity of FDA Feedback
FDA recommends that “if more than 1 year has passed since our last feedback on key clinical trial design elements without a submission to the Agency, the sponsor should contact the review branch to confirm that the previous advice is still valid. The reason for this recommendation is because clinical practice (including available alternative therapies or diagnostics) is rapidly evolving.” The guidance clarifies that a new Pre-Sub to the Agency is not recommended (If >1 year has passed). Instead, confirmation that prior feedback is still valid can be accomplished through a phone call to the lead reviewer or branch chief. This suggests that if prior feedback isn’t valid, you may be able to receive FDA’s “current thinking” without having to submit a Q Sub.
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52. Best Practices for Q Sub Meetings with FDA
Follow the suggested logistics in the guidance document
Provide several options for dates to remain flexible
(FDA will contact you within 7 days of Pre Sub acceptance to schedule.)
Think carefully about what you want to get out of a meeting.
Submit focused questions in advance
Develop the agenda based on these questions
Bring the right experts to execute your objectives
Do not expect FDA to:
Make guarantees or binding commitments
Hold to informal feedback provided years ago
Approve a study or clear/approve a device at the meeting
Act as a consultant
Have iterative meetings on the same topic – make the most of each meeting
US FDA Pre-Submissions (Q Subs) © 2016 Phil Triolo April, 2016

53. Best Practices for Q Sub Meetings with FDA
Do not waste time on lengthy presentations on your product. Focus on Questions and FDA Feedback.
Assign different team members responsibility for each question, and have them ask others to contribute, if needed.
LISTEN !
Do not volunteer information that is not needed to respond to questions.
Never commit to performing additional studies during the meeting, unless you have already considered performing these tests and determined they would be OK.
Do not ask open-ended questions, unless it would be better to know what the FDA wants you to do NOW as opposed to later.
Write Minutes that accurately reflect meeting discussions.
US FDA Pre-Submissions (Q Subs) © 2016 Phil Triolo April, 2016

54. Summary
As resource requirements are dependent upon regulatory requirements, the early identification of applicable regulatory requirements is essential for planning purposes and to estimate the time and costs associated with product development. Pre-sub meetings are highly recommended, as they focus activities and force the early creation of regulatory documents that will be used, in their final forms, in regulatory submissions. They save time, also, if used judiciously.
US FDA Pre-Submissions (Q Subs) © 2016 Phil Triolo April, 2016

55. Questions or Comments
Feel free to contact me: Phil Triolo PhD RAC Phil Triolo and Associates LC or (office/cell) Fax
US FDA Pre-Submissions (Q Subs) © 2016 Phil Triolo April, 2016