FDA Webinar

Moderator: Irene Aihie

6-11-19/3:00 pm ET

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FDA Webinar Q-Submission Program for Medical Device Submissions

Moderator: Irene Aihie

June 11, 2019

3:00 pm ET

Coordinator: Welcome and thank you for standing by. At this time, all participants are in a 

listen-only mode until the question-and-answer session. Today's conference is 

being recorded. If you have any objections, you may disconnect at this time. I 

will now introduce your conference host, Ms. Irene Aihie. You may begin.

Irene Aihie: Hello, and welcome to today's FDA webinar. I am Irene Aihie, CDHR's 

Office of Communication and Education. On May 7, the FDA issued the final 

guidance request for feedback and meeting for medical device submission, the

Q Submission Program. The FDA's Q submission program provides 

submitters an opportunity to have early collaboration and discussions about 

medical device submission. This final guidance clarifies the available way 

submitters can request feedback or a meeting with the FDA about potential or 

planned medical device or device-led combination product submission.

Today, (Susannah Gilbert) acting Policy Analyst in the Office of Regulatory 

Programs here in CDRH will discuss the final guidance. Following the 

presentation, we will open the lines for your questions related to the 

information provided during the presentation. Additionally, there are other 
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subject matter experts here to assist with the Q&A portion of our webinar. 

Now I give you (Susannah).

(Susannah Gilbert): Hi, I’m (Susannah Gilbert). I'm an acting Policy Analyst who works on 

Q-Submissions, and today I will be talking about the Q Submission Program 

for medical device submissions and specifically the new Q-Submission 

guidance document that was published in early May.

During my presentation, I will start with today's objectives and provide some 

background on the Q Submission Program. I will go over what the QSubmission Program is and the scope of the new guidance, and then I will go 

into some of the specific types of Q-Submissions and discuss the significant 

changes that were made in the new guidance document.

I would like to start by going through a few definitions for you and explaining 

some of the common abbreviations that I will be using today. To begin with, 

the Q Submission is a mechanism to request different types of interactions 

with FDA. We often abbreviate the word submission and refer to this as a QSub. I will discuss the types of Q-Subs more later, but one specific type of QSubmission is a Pre-Submission, and similarly, this is often abbreviated as a 

Pre-Sub. 

I also want to briefly discuss a few marketing submissions that I'll be 

referencing during this presentation. A pre-market approval application, or 

PMA, is a mechanism to request approval for a Class 3 medical device. An

investigational device exemption, or IDE, is a mechanism to request approval 

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

of a device. And an investigational new drug, or IND, is a mechanism to 

request a drug or biological drug be used in a clinical investigation.
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On May 7, 2019, the final FDA guidance entitled ‘Request for Feedback and 

Meetings for Medical Device Submissions: the Q-Submission Program’ was 

published. My goals today are to provide an overview of the scope of this 

guidance document, provide an overview of the different mechanisms 

available to request feedback from or with interactions with FDA, and to 

review significant changes that were made in this guidance document.

To begin, I'm going to go through a little of the Q-Submission Program 

history. In 1995, a Pre-IDE program was established. This provided a way to 

request feedback about future IDE submissions. Over time, as the utility of 

these submissions became evident, we started receiving requests for feedback 

to discuss planned submissions of other types such as PMAs or 510(k)s. 

In 2013, the program was formally reestablished as the Pre-Submission or 

Pre-Sub Program and was expanded to include requests for other submission 

types in addition to IDEs. The Pre-Sub Program was a mechanism to request 

feedback on planned marketing submissions, and was not specific to any one 

type of submission, which meant that submissions to this program could be 

Pre-PMAs, Pre-510(k)s or Pre-IDEs, and a formal guidance document 

describing this program was issued in 2014.

Since then, the program has continued to grow and include different types of 

feedback requests in addition to Pre-Subs, and the Pre-Sub Program has 

further evolved into what is now the Q-Submission or Q-Sub Program. This 

program now includes Pre-Subs as one type of Q-Sub, but also includes other 

types of requests for feedback and interactions. This new guidance document 

describes the different types of request that are encompassed within the Q-Sub 

Program.
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Now that we've gone through the evolution of how the Q-Sub Program was 

established, we can get into what the Q-Sub Program actually is. The QSubmission Program is a voluntary program that provides a mechanism to 

request different types of interactions with FDA regarding medical device 

submissions. The request that comes into the FDA is called a Q-Submission,

or a Q-Sub, and can request interactions to discuss a number of different 

topics and can request different types of feedback. 

As I mentioned when discussing the history of the Q Submission Program, 

one type of Q-Sub can request feedback about potential or planned medical 

device submissions. Another type of Q-Sub can request certain formal 

determinations that are not standalone marketing submissions or research 

authorizations such as accessory classifications or study-risk determinations. 

Depending on the topic and the submitters preference, these requested

interactions can consist of written feedback, a face-to-face meeting, or a 

teleconference. The Q-Sub Program is made up of a number of different types 

of Q-Subs which are discussed in the guidance document and we'll go into 

some of these in more detail today. 

Since the Q-Submission Program has expanded to include Pre-Submissions as 

well as additional requests for interactions from FDA, this guidance document 

explains the purpose for each of the different Q-Sub types. It outlines Q-Sub 

processes including submission content, feedback mechanisms, meeting 

format and documentation via minutes, and review timelines. This 

information is all provided for the main Q-Sub types, however, there are other 

Q-Sub types identified in the guidance that are discussed in less detail. The 

guidance explains that these Q-subs are covered in more detail in other 

guidance documents, and provides specific references for learning more about 

them.
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There are also some requests for feedback that do not fall into the scope of 

any specific Q-Sub types, and even though they are outside the scope of the

Q-Sub Program, these requests are still tracked by FDA as Q-Submissions. 

The guidance also discusses this process and outlines some examples of these 

requests. 

The group of the five most common Q-Subs are considered the main Q-Subs 

and are discussed in most detail throughout the guidance document. These 

five Q-Sub types can be seen in the upper group of the Q Submission types on 

this slide and include Pre-Sub meeting requests, Pre-Sub written feedback 

requests, Submission Issue Request or SIRs, informational meeting requests

and study risk determinations. For these five Q-Sub types, the guidance 

outlines Q-Sub processes including feedback mechanisms, meeting format

and documentation via minutes, and review timelines. 

The other group of Q-Subs that are identified in this guidance but are covered 

in less detail are each described more extensively in their own corresponding 

guidance documents. These can be seen in the lower group here and are PMA 

Day 100 Meetings, Breakthrough Device Designation requests, Interaction for 

Breakthrough Devices, Early Collaboration meetings, and Accessory 

Classification requests.

Next, I'm going to provide some additional information on the different types 

of Q-Subs. We're going to start with Pre-Submissions which are the most 

common types of Q-Subs. The Pre-Sub is a formal request to FDA for 

feedback that will be provided in the form of a written response, and possibly 

a subsequent meeting, prior to an intended pre-market submission, IDE, 

accessory classification request or CLIA Waiver.
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Depending on the type of interaction requested, there are two types of PreSubmissions. In a Pre-Sub meeting request, FDA provides written feedback

followed by a meeting, either a teleconference or a face-to-face meeting. In a 

Pre-Submission feedback request, FDA provides only written feedback. 

Although they have different feedback mechanisms, both Pre-Sub meetings 

and written feedback requests serve the same purpose and can be used to 

discuss issues relevant to a planned marketing submission, IDE or CLIA 

Waiver. 

Just as originally IDEs were submitted to discuss potential or planned IDE 

submissions, Pre-Subs are submitted to discuss potential or plan IDEs, PMAs, 

HDEs, De Novo requests, 510(k)s, Duals, BLAs, INDs, Accessory 

Classification requests or CLIA Waivers. Pre-Submissions are used to help 

guide product development, develop study protocols or prepare an application,

and specific questions should be included in Pre-Submissions so FDA can 

provide useful feedback.

We have found that the most productive conversations occur when PreSubmissions include focused questions and do not try to cover too many 

different topics. Therefore, in the new guidance we recommend that PreSubmissions are limited to three to four substantial topics in order to have the 

most useful meetings.

Pre-Submissions are the most common type of Q Submissions. They are also 

the only type that have MDUFA commitments. The specific MDUFA

commitments relevant to Pre-Submissions are included throughout the 

guidance document. For example, the goal times for providing feedback and 

submitter responsibility for drafting meeting minutes are included in the 

section that describes the Pre-Sub process. That same section specifics that 

FDA intends feedback provided in response to a Pre-Sub will not change 
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provided the information submitted in a future IDE or marketing submission 

is consistent with that provided in the Pre-Sub, and that the data or other 

information in the future submission do not raise any important new issues 

materially affecting safety or effectiveness.

The guidance document also includes a new Pre-Submission checklist in 

Appendix 1, and examples of questions that can lead to productive 

interactions in Appendix 2, both of which were agreed to in the MDUFA 

commitment letter. 

Now we'll move onto Submission Issue Requests, or SIRs, which are the next 

most common type of Q-Submission. These submissions are requests to 

discuss outstanding review issues that were provided in a marketing 

submission hold letter, IDE letter or an IND clinical hold letter. Either written 

feedback or a meeting is requested in a Submission Issue Request. These 

requests are not necessary for simple questions about clarification of issues in 

a letter where the involvement of management is not needed. For example, 

minor clarification questions or administrative issues that can be addressed by 

the leader reviewer. They are also not necessary to discuss issues while a file 

is under active review. This would be done via interactive review. Instead,

Submission Issue Requests can help submitters determine how to respond to 

outstanding questions in formal responses. 

Before the release of the new Q-Sub guidance, this type of Q-Sub was called a 

Submission Issue Meeting, or SIM. Although the name has changed, they still 

provide the same purpose, which is to help move a project forward by 

facilitating interactions with FDA and discussing approaches to address 

deficiencies. 
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Study Risk Determinations are a little different than the previous two types of 

Q-Submissions we have discussed, and they request a different type of 

feedback. Study Risk Determinations are used when a submitter is interested 

in obtaining a significant risk or non-significant risk determination for a future 

clinical study. FDA reviews these requests and provides a final determination 

in writing and whether the proposed clinical study is exempt from IDE 

regulations, is basic physiological research, is not non-significant risk or is

significant risk.

For non-exempt studies, the regulation specifies that sponsors are responsible 

for making the initial risk determination and presenting it to an IRB. FDA is 

available to help make that risk determination, and FDA is the final arbiter as 

to whether a device study is significant or non-significant risk.

Informational Meetings are also different than the other types of QSubmissions. Informational Meetings are requests to present information to 

the FDA without the expectation of official feedback. These meetings can be 

used to provide an overview of ongoing device development when multiple 

submissions are planned in quick succession, or to introduce new technology 

to the FDA review team. 

While the reason for these meetings can vary, their intent is to share 

information with the FDA and provide an opportunity for interactive dialogue. 

Although FDA does not provide written feedback, they can ask questions 

during the meeting and may offer suggestion regarding future submissions. 

As with other types of Q-Submission meetings, these are all documented with 

meeting meetings.

Informational Meetings can also be used to document requests that don’t fall 

within the scope of any type of Q-Submission. When used this way, 
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Informational Meetings can include FDA feedback. The new guidance 

document includes examples of interactions that may fall outside the scope of 

an existing Q-Submission type, but may be tracked as an Informational

Meeting Q-Sub. 

In addition to the five most common Q-Submissions, which are the ones 

discussed in the most detail throughout the guidance document, there are also 

some types of Q-Subs that are discussed with less detail in this new guidance 

document. As I mentioned earlier, these include PMA 100 Day Meetings, 

Breakthrough Device Requests, Interaction for Breakthrough Devices, Early 

Collaboration Meetings and Accessory Classification Requests.

The new Q-Submission guidance does not include an in depth discussion on 

these Q-Sub types because their policy and procedures are already described 

in other FDA guidance documents. The Q-Sub guidance document provides 

references for where to find additional information on each of the additional 

Q-Sub types. 

Now that we've gone over the scope of the Q-Submission Program and the 

different types of Q-Submissions, I would like to go over the significant

changes that were made in this guidance document. As I mentioned earlier, 

Pre-Submissions were included in the MDUFA IV Commitments, and so in 

developing this Q-Submission guidance document, we included the goals 

from the MDUFA IV Commitment Letter. 

Since there are additional goals when a meeting is requested, and therefore a 

different review process, we have separated requests into pre-submission 

meeting requests and pre-submission written feedback requests. The guidance 

document separates these accordingly when discussing timelines and 

processes, and we request that Pre-Submissions specify if they're requesting 
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written feedback only or a meeting, which also includes written feedback prior 

to the meeting.

These MDUFA milestones include completing an acceptance review, or RTA,

within 15 days of receiving a Pre-Submission, and for Pre-Submission 

meeting requests the milestones include determining a meeting date by Day 

30, and providing written feedback five days before a meeting or by Day 70,

whichever is sooner. 

This guidance document also made changes regarding the Acceptance 

Review, or RRA, checklist. It specifies that Submission Issue Requests and 

Informational Meetings no longer receive an RTA review. It also includes an 

updated, streamlined, RTA checklist for Pre-Submissions which is found in 

Appendix 1 of the guidance document. 

The other changes that were made in this guidance document are regarding 

Submission Issue Request feedback and review timelines. These requests were 

previously called Submission Issue Meetings, or SIMs. However, this 

guidance specifies that feedback for these requests will be provided either in 

the form of written feedback or a meeting, and that the submission should 

include the preferred feedback mechanism.

Since not all Submission Issue Requests will be closed with a meeting, the 

name has been changed to Submission Issue Requests, or SIRs. 

The major change to Submission Issue Requests is the development of a twotiered review timeline. This new review timeline is based on how much time 

has passed between when the associated letter was sent, and the submission 

issue request was received. Based on this time, if a Submission Issue is 

received within 60 days of when FDA sent the associated letter, FDA will aim 
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to provide feedback within 21 days. However, if more than 60 days have 

elapsed since the associated letter was sent, FDA will aim to provide feedback 

in 70 days.

So I know we've gone over a lot of information today in a short amount of 

time, so before I finish I'm going to summarize some of it for you. Overall the 

Q-Submission Program has been extended to include a variety of submission 

types that all provide a mechanism for submitters to request FDA interactions. 

And each type of Q-Submission has its own review process and timeline. This

new Q Submission guidance document goes through and describes the various 

Q-Sub types and corresponding timelines,. and provides resources for the Q 

Submission types with policy and procedures that are described in more detail 

in other FDA guidance documents.

While the guidance document describes the differences in the processes for 

the different Q-Sub types, it also explains that all Q Submissions regardless of 

type should be formally submitted in electronic copy format to FDA via the 

document control center. It explains that related Q-Submissions are all 

tracked with supplements and amendments, regardless of the Q-Sub type, and 

it describes the meeting formats and submission of meeting minutes.

Now that we have gone through all this information, I want to provide a few 

resources that may be useful, which you can find in the guidance document. 

This slide includes a link to the final Q-Sub guidance document that I've been 

discussing. It includes links to each of the other guidance documents that can 

provide more information about the additional Q-Subs that aren't discussed in 

depth in this guidance. And it includes a link to the eCopy guidance 

document. Hopefully you will find these references useful if you have 

questions about any of these specific areas. 
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In a moment we will take questions, but if you have any questions at a later 

time, you can reach us at the email addresses provided here. This now 

concludes my presentation. I will take questions.

Coordinator: We will now begin our formal question and answer session. If you would like 

to ask your question by phone, please unmute your phone. press Star 1. Only 

record your first and last name. To withdraw your question, you may press 

Star 2. Once again to ask your question by phone, please press Star 1 and one 

moment for the first question.

(Susannah Gilbert): I want to also introduce Josh Nipper who is sitting here with me. He is the 

Director of Division of Submission Support who will be helping out with 

some of the questions.

(Josh Nipper): Hello.

(Susannah Gilbert): While we wait for the first question to come through, I also want to start 

by addressing a common question that we receive about why the Submission 

Issue Request timeline was changed to include two different feedback 

timelines.

The FDA wants to encourage a shorter hold time and prompt resolution that 

will support achievement of the MDUFA shared outcome goals for total times 

and decisions, and we believe this timing will help achieve this goal. In 

addition, when Submission Issue Requests are received soon after a hold letter 

or an IDE letter is sent, the issues being discussed are still current. In contrast 

when a Submission Issue Request is received many months after the review is 

completed and a letter was sent, the review team may have to refamiliarize

themselves with the issues previously discussed.
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This additional step adds time to the overall process. So the idea of separating

this out into a two-tier timeline was so that we can help have everything fresh 

in everyone's mind as well as get a shorter turnaround time.

And now we'll see if there's any questions on the line.

Coordinator: And the first question is coming from (Dan Dillon). Your line is open.

(Dan Dillon): Hello, thank you for this presentation. It was very helpful. Learned a few 

things that I hadn't heard before. But I did want to ask a question about the 

timeframes for submission issue meetings. I was doing the math and 60 days 

plus 70 days, that's 130 days. The 510K response letter is supposed to get in 

within 180 days. If you take, you know, 30 days to write things up after you 

meet with FDA that sort only gives you until what Day 80. So if we get to the 

point where we're still working through issues. We suddenly realize we have 

an issue. We want to talk to the FDA but we're past Day 80. What would you 

recommend? Do we still try to get a submission issue done and hope it's going 

to get done faster than 70 days? Or what would you recommend?

(Susannah Gilbert): You know I think that’s a hard question and it depends a little bit on the 

type of questions you're going to have. Often if it has taken you that long to 

come up with the questions and realize that there are issues you need to 

discuss; chances are it's going to take longer to review as well. And that was 

one of the reasons that we wanted to give the review team longer to make sure 

they're able to provide a full review and useful feedback. 

I always think it's a good idea if you want to talk to the review team to come 

in and, you know, hope that the time will be shorter, if that's the case. And, 

you know, the review team will work with you obviously, as much as they 

can, to get things back within the correct timeframe, it just depends on the 
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specifics. Also, you know, if it does take longer at least you still have that 

feedback for a later time.

(Josh Nipper): This is (Josh) to add to that. I mean I think it's perfectly okay to reach out to 

the lead reviewer of the review management that you're dealing with and, you 

know, discuss what the expectations are. I mean 70 days is our goal. That's the 

maximum so to speak that we would take. But if it's a, you know, a single 

question it's entirely possible that the review division may have resources to 

do that before 70 days. You know, of course if you're asking, you know, 10 

or 15 follow up questions on a very long deficiency letter and you kind of wait 

until it's essentially very close to be due, then you do the run the risk of having 

the 510(k) deleted. The same would hold true for a PMA just with a longer 

timeframe out.

(Dan Dillon): Okay, thank you.

Coordinator: The next question is coming from (Brian Carney). Your line is open. 

(Brian Carney): Hi, good afternoon. Thank you very much for this information. It's been 

extremely helpful. I’m looking to gain some perspective on FDAs current 

thinking around concurrent pre-submission for a particular product and 

development mainly around the fact that some products development 

initiatives are such - are so big in scope that in order to get directed questions 

from the FDA to get valuable feedback to the sponsor, sometimes the sponsor 

is submitting multiple pre-submissions around the same product. If you could 

elaborate on what the current thinking in and perspective, that would be 

appreciated.

(Susannah Gilbert): I want to first clarify to make sure I understand what you're asking. Are 

you asking about the possibility of coming with multiple pre-submissions at 
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the same time? Or coming in with multiple pre-submissions in succession 

about the same device?

(Brian Carney): I think it's both. So if we could, you know, multiple Pre-Subs around different 

topics. So for instance reliability or cybersecurity regarding a particular 

product and as well as maybe having a tiered approach in terms of submitting 

one in Month 1 and then in Month 2 submitting another one on another topic.

(Susannah Gilbert): You know, if you're finding that you come in with one and you have 

questions on another topic at a later time, you're absolutely allowed to come 

in. That's one of the reasons we talk about how submissions for the same 

devices with the same intended uses are tracked. So if you came in with one,

and came in with a different topic for the same device later, it would be 

tracked as a supplement and kept in the same Q-Sub family so that the review 

team can keep the information on those together. 

It also means that you would be providing specific topics of conversation that 

are more limited and you won't necessarily ask everything in one submission. 

So we do support that, but it depends on the timeline. If you are going to 

submit them when they overlap it might not be as convenient because the 

review team might still be working on the previous submission that you had,

and they might not really have the resources to then have a different team 

work on the next one. Or it might be a different team, which in case you'd 

have different people reviewing it when it would be preferable to have the 

same review team working on it if you have more consistent feedback.

(Brian Carney): Okay so to clarify, if there is an active review on one pre-submission for a 

product and then a subsequent supplemental Pre-Sub on a different topic for 

the same product is submitted during that active review, it's most likely not 

going to be reviewed by the same team. And then it would not be valuable.
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(Susannah Gilbert): It would really depend on the resources of the review team and it's hard 

for us to make a general comment on that.

(Josh Nipper): I would also say, you know, I don't - I think if you have questions that are that 

close together in time, it would be better to include those in a more 

comprehensive pre-submission rather than, you know, kind of doing them 

piecemeal. You know, we do ask, at least for a meeting, that the number of 

questions be limited in scope., That's really just due to meeting management, 

we really find that, you know, three or four meeting topics or main topics in 

the meeting is the best or the easiest to get through. 

But if you have multiple sets of questions that can be okay with written 

feedback, that can be done in a Pre-Sub. I would not - I don’t think we should 

have multiple pre-submissions for the same product and same indication open 

at the same time. Now if you had the same device and you're looking for, you 

know, a cardiac and a neuro, two completely different indications, that would 

be a different case and we would, you know, be okay with having two 

different Pre-Subs go to two different review groups.

(Brian Carney): Okay, thank you.

Coordinator: The next question is coming from (Lupe Kagan). Your line is open.

(Lupe Kagan): Yes, thank you very much. This has been a very informative. However, my 

question was very similar to the gentleman that just occurred regarding 

concurring Pre-Subs. If you have, for example, just information that you want 

to find out from the FDA whether two devices with the same intended use, 

however, just monitoring different stage of the disease, would that require a 

Pre-Sub just to find out whether you can submit one PMA or two? Or could 
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you just call up the FDA and find out if that would require separate PMAs?

And I'm saying PMA because it's a Class 3.

(Josh Nipper): Sure, so I think it could be somewhat variable. If you have a simple question

of what is the best way to submit this. I mean we see, you know, being the 

former director of the PMA staff, we see the question of ‘what's the best 

supplement type’ or ‘how do I submit this’ all the time. That's certainly 

something we would say, reach out to the lead reviewer or the management 

that you've been dealing with in the past, and float the question out. 

You know, we certainly don't want every question coming to CDRH to be a 

Pre-Sub or a Q-Sub, that is not the intent of the program or of the guidance. If 

it's, you know, a complicated question that we feel would need additional, you 

know, analysis or a reviewer to look at, that might be something then that a 

reviewer is going to say, you know, look I don't have enough information to 

answer this on the phone. Or even by an email, you know, please submit a 

Pre-Sub and we can discuss that in further detail.

(Lupe Kagan): Okay, because it may require using maybe one clinical evaluation that would 

capture for both. So.

(Josh Nipper): Yes, I mean the specific case you're describing sounds like a Pre-Sub could be 

useful to, you know, to ask that question. And to, you know, kind of layout 

your regulatory strategy. That being said, you know, on a broader scale, I 

think it's perfectly acceptable to, you know, reach out to that lead reviewer or 

the branch chief first and ask your question. And, you know, they may direct

you to the Q-Sub in which case, you know, I think it would fit here.

(Lupe Kagan): Perfect okay, thank you so much. It's been really helpful.
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Coordinator: The next question is coming from (Allison Komiyama). Your line is open.

(Allison Komiyama): Hi, thanks so much. I guess can I just - I want to make a comment to the 

last few callers because I think just from industry perspective, we've had a few 

cases where we have submitted a Pre-Sub for two different branches, totally 

two different indications within one Pre-Sub. And at that point, FDA did bring 

both review team or both branches into the room and they found it very 

helpful. And we found it very helpful because it was clear that it was going to 

be two different filings. 

And to the previous caller, the multiple submissions, we have had FDA 

suggest please submit when you're ready, because we had, you know, with the 

big information, we had one file or one Pre-Sub that was just a clinical 

protocol. And the other file we submitted later that was just the pre-clinical 

data and they actually asked us to send them in different Pre-Subs so that they 

can have the different reviewers or consults on that file reviewing them at the 

same time.

So it didn’t seem to impact it. Anyway, I'm just, yes, I see the FDA and the 

different branches work differently just based on their - what the lead reviewer 

and the branch chief or associate director want.

Anyway, but my question is with the feedback, the requested feedback for 

submission issue requests. Is for, at least the slide says you either want written

feedback or a meeting for those types of request. Does FDA - FDA will not 

provide written feedback if you request a meeting. Is that correct?

(Susannah Gilbert): The understanding with the implementation of this guidance is that the 

standard from now on is going to be either request a meeting or you request 

written feedback. I could see there being certain exceptions depending on the 
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situation or the review team's resources. But in general, it is now going to be 

separate and one way or the other.

(Allison Komiyama): Okay, would industry be required to submit the meeting minutes if we do 

have a teleconference meeting for that?

(Susannah Gilbert): Yes, and meeting minutes are always required if there's a meeting.

(Allison Komiyama): Okay, thank you so much.

Coordinator: The next question is coming from (Carl Fischer), your line is open. 

(Carl Fischer): Hello and thank you for holding the webinar. This relates to situations where 

following a Pre-Sub, a potential submitter and a review team disagree about 

the type or amount of data needed to support an application. And recognizing 

that the feedback from the Pre-Sub is not binding and the guidance does 

address situations where if the applicant chooses another path, the question is 

if a submitter believes that the feedback, either written or during the meeting,

from the review team relating to the data in an upcoming submission is not 

consistent with least burdensome principles, is it appropriate for the applicant 

to throw a least burdensome flag prior to the submission? If not, what, if any, 

is the informal appeal process prior to submission?

(Susannah Gilbert): Can you give us one moment to discuss that?

(Carl Fischer): Sure.

(Josh Nipper): Hi, (Carl). This is (Josh).

(Carl Fischer): Hi (Josh).
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(Josh Nipper): I think I understood your question. If I mischaracterize it, just please let me 

know. So you're talking about - are we talking about a pre-submission or a 

submission issue meeting? That is somewhat different.

(Carl Fisher): We're talking about a meeting prior to a submission.

(Josh Nipper): Okay, so I think if you're talking about a meeting, about a Pre-Sub prior to 

submission, you know, we do not have the least burdensome flag in place for 

that. I think it's perfectly fine if you, you know, disagree with the, you know, 

if you disagree with the concept of it being least burdensome, it's perfectly 

okay to discuss that within the actual submission within the 510K or the PMA. 

There's, you know, that's certainly your right to do. 

You know, I don't think we have or have any plans to create an appeal process 

for the Pre-Sub, because it is, you know, our best feedback at the time. We 

acknowledge we may not have all of the information. We acknowledge that 

things can change. But I don't think that, you know, there's any plan in place 

to have at least burdensome flag, you know, that would kind of go up the 

chain of management prior to an actual marketing application.

You know, again, it's perfectly acceptable to, you know, to raise the concern 

in, you know, the cover letter and the body of the submission. You know, if 

you have a concern, you know, you can certainly reach out to the 

management. I mean our management directories are, as you know, publicfacing. If you get feedback from a reviewer, you know, I always recommend 

the first step, talk to the, what we're now calling assistant director or the 

former branch chief. There's also the division director. 
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You know, so there are recourses that you can use to talk informally. But we 

don't have any kind of plans to extrapolate the least burdensome flag down to 

Pre-Sub. If you're at the submission issue phase, you know, it's a 510K, you 

have the option to throw the least burdensome flag which has been described 

in other webinars. And if it's a PMA or another type of marketing application, 

there's certainly the option to, you know, raise the issue to management. It's 

not typically the least or it's not traditionally the least burdensome flag, but 

you can certainly raise that up the chain.

(Carl Fischer): Thank you, just to clarify. So it could be appropriate to have that discussion 

with management prior to the submission as opposed to raising it during the 

submission and then possibly or predictably leading, needing to throw the flag 

after an AI.

(Josh Nipper): Correct, you know, there's - we always encourage if you have any kind of 

questions or concerns, you know, we always encourage industry to either, you 

know, first step is to reach out to the reviewer And if that is, you know, if 

you're not getting resolutions, then you know, go up that management chain. 

You know, that being said, a lot of pre-submission feedback is reviewed by 

management. So in most cases, they will be aware of the issue. You know, if 

it's a Pre-Sub meeting usually you will have at least some kind of branch or 

team level management there if not division management.

So, you know, I would expect that at least the frontline management to be 

generally in agreement with that and maybe not always the case. And so it 

never hurts to, you know, to raise that up the chain and to discuss concerns. 

You may get to the point where, you know, you're going to get a major 

deficiency letter or an AI letter for a 510K in which case, there are options 

once that letter goes out. 
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(Carl Fisher): Great, thank you so much.

(Josh Nipper): Yes.

Coordinator: The next question is coming from (Mark SiSero). Your line is open.

(Mark SiSero): Hi there. Thanks for the presentation. I just had a question about cost 

associated with pre-submissions. If you could comment on if there are any 

costs and what they are for small or medium-sized entities. As well as if you 

can comment on if there's any guidance around when a pre-submission should 

be done in person versus via webcom.

(Susannah Gilbert): So to address the first question. There are no costs associated with QSubmission or Pre-Submissions at this time. And then your second question 

was asking about the difference between an in-person meeting and a 

teleconference, is that correct?

(Mark SiSero: That's correct, yes.

(Susannah Gilbert): So that tends to be a personal decision. There are people who prefer to 

come in person and have that interaction face-to-face with the review team 

and have that personal interaction. And maybe potentially show a demo or 

something like that. Other people find that it's much harder to schedule a faceto-face meeting in a shorter period of time and they prefer to have a 

teleconference which might be a little bit sooner. And everybody we talk to 

really finds that they have their own preference for whichever is the preferred 

method.

(Mark Cicero): Okay, thank you.
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Coordinator:: The next question is coming from (Jeff Gray). Your line is open.

(Jeff Gray): Good afternoon. My question is related to the confidentiality of the 

information that is submitted through the Q-Sub program. Is there any 

elements of this that would be accessible through the Freedom of Information

Act? And also with regard to decisions that are written that will 

(unintelligible) FDA conditions, are they are all publicly accessible?

(Susannah Gilbert): Give us one second to discuss that, please. Thanks for holding on. So all 

the information submitted is considered confidential. I am not sure about the 

answer to your question about if these can be accessible via of the Freedom of 

Information Act. My recommendation is you contact us at one of the email 

addressed I provided. And we can look into this for you and get back to you.

(Jeff Gray): Okay, thank you.

Coordinator: The next question is coming from (Greg Harris). Your line is open. 

(Greg Harris): I’m sorry, my question's answered. Thank you.

Coordinator: Once again if anyone does have a question, please press Star 1 and record 

your name when prompted. The next question is coming from (Roseita 

Esfand). Your line is open.

(Roseita Esfand): Hello, thank you for the seminar. My question is regarding the duration of the 

meeting. I’m aware that we usually book the meetings in 60 minutes. Is it 

possible to have a longer meeting?

(Susannah Gilbert): So typically meetings are set for one hour based on our experience that we 

have the most productive conversations in that amount of time. There may be 
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exceptions to that depending on the situation. But typically, it is better to have 

a one-hour meeting so that it is more efficient, and everybody stays focused 

on the information. 

(Roseita Esfand): Thank you.

Coordinator: The next question is coming from (Blesson Abraham). Your line is open.

(Blesson Abraham): Hi, my question is in regard to let's say it's a sponsor developing a device. 

And you've identified a predicate for the new device. Do you need to 

complete all risk analysis activities before you can get feedback on the FDA 

regarding your proposed verification, validation activity that you plan to 

submit for your 510K? Or can you submit the, your device prior to having 

identified any of the risk?

(Susannah Gilbert): Are you asking about before you submit the marketing application or 

before you submit the pre-submission?

(Blesson Abraham): Before submitting the pre-submission. The request would be for an 

informational meeting and for an informational meeting can I expect feedback 

on verification validation activity and whether risk analysis needs to be 

completed so FDA gets a full understanding of the device? Or I can skip the 

risk analysis?

(Susannah Gilbert): Well it sounds like this is the kind of question that would be part of a presubmission request. And typically it depends on the question you're asking. 

But the only information that needs to be submitted is relevant to the specific 

questions. So you wouldn't have to complete all the testing or all the data 

collection beforehand as long as it's sufficient information for the review team 

to understand what you're asking and provide feedback.
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( Blesson Abraham): Okay, thank you.

Coordinator: The next question is coming from (Anthony Gonzalez). Your line is open.

(Anthony Gonzalez): Hello. I with Biocom. We're California's Life Signs Trade Association. 

And I run the artificial intelligence committee. And oftentimes some of our 

companies are looking to not be regulated. And I understand there's currently 

framework that's being proposed and outlined but is it a proper pathway to 

engage in an informal meeting to get clarification on, you know, where the 

regulatory pathway may lie. Because a lot of these founders are technical 

founders and don't necessarily have a life science background. And it is kind 

of ambiguous as to whether or not they're going to be regulated by the FDA. 

And I was wondering if you have any opinion or comment on that.

(Susannah Gilbert): I’m not familiar with that specific area. In general, my recommendation 

would be that you reach out to the team that would be within your area. And 

then if they think it would be helpful to talk about this they can recommend 

you to the specific support team or somebody can work on the policy with you 

on this.

And then i if you need to have a meeting, you can have an information 

meeting of some sort to prevent - to present this. And talk about sort of the

next steps forward.

(Josh Nipper): And this is (Josh) just to add onto that. You know, there's - we're well aware 

there's a lot going on with like the digital health area and software as a 

medical device. You know, we have not just the review teams, but we have 

special teams that can help assist with some of those questions. The Pre-Sub 

or even the Q-Sub program is not a definitive pathway on how to regulate the 
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device. It is basically intended for, you know, feedback and general 

suggestions. 

There is a 513G program that you can go to if you're, you know, primary 

question is ‘am I a medical device’ or ‘what classification am I’. That being

said, we're, you know, we fully support sending in pre-submissions or even 

information meetings to say, you know, here is my product, here's where we're 

thinking. You know, do you have any feedback on the development plan? If 

there are questions about whether or not it will be regulated, we often will 

bring those experts in to have some of those initial discussions.

Again, you wouldn't likely get a formal decision about that, you know, under 

the Pre-Sub program, but you may get general suggestions or feedback on, 

you know, well if you say this, you would trip a limitation and you would be 

considered a Class 2, you know, XYZ type of device. However, if you only 

claim this, or if your software is limited to that, then, you know, we would 

consider that, you know, whatever it is, you know, software that we don't

regulate. 

So it's a very complicated question. But we would certainly support the PreSub or Q-Sub program to, you know, help kind of guide you in those 

questions.

(Anthony Gonzalez): Excellent, thank you. I will definitely communicate that to our committee.

Coordinator: The next question is coming from (Melissa). Your line is open.

(Melissa): Hi, thank you for the presentation and the opportunity to ask questions. I just 

have a question about Q-Sub and feedback. So if the method of feedback 

requested was written, but after written feedback was received, it was desired 
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to have a meeting or teleconference. Is there a channel to do this? And if so, 

what's the timeline?

(Susannah Gilbert): So yes, there's the opportunity to do that usually. It depends, again, on the 

resources of the review team. And usually if they're going to have a meeting 

after the feedback is sent, because it hasn't been planned ahead of time, it 

might take longer to schedule, but it's really going to depend on the 

availability of their review team and their management. It's one of the reasons 

why, if you might want it, we do like to schedule them ahead of time, and we 

do have meetings scheduled early in the review period with Pre-Sub meeting 

requests to make sure that, you know, you are looking ahead of time. at 

everyones schedule, because people all have different schedules and it's hard 

to get everyone together. 

(Josh Nipper): Yes, and this is (Josh) again. I would - I think the general recommendation 

that I would have is, you know, it's you can request - submit the Pre-Sub 

requesting a meeting. It's easier to cancel a meeting that's already on the books 

than it is to add one that hasn't been planned. So if you - what we see a lot of 

times is, you know, toot our horn a little bit. We send the feedback and the 

industry says, you know, this was great. We don’t really have any further

questions and we don't want to have the telecon. Or we don't want to fly out to 

meet you. And the meeting is canceled. And that's perfectly okay on our end. 

We have mechanisms to do that. 

But if it's the flipside where you get the feedback and you say now I want a 

meeting, that becomes a much harder thing to do just due to scheduling. So, 

you know, my general recommendation is request the meeting up front. And 

you can always cancel it if you decide you don't need it.

(Melissa): Okay, thank you.
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Coordinator: The last question is coming from (Lisa Muldanado). Your line is open.

(Lisa Muldanado):Yes, thank you for today. What is the expected timeframe for FDA response 

after the submission of our meeting meetings?

(Susannah Gilbert): So I believe that usually there's a 30-day turnaround for FDA to review 

those meeting minutes and then respond to you.

(Lisa Muldanado):All right, thank you so much.

Coordinator: That will conclude today's Q & A portion. I'll now turn the call over to Ms. 

Irene Aihie You may begin.

Irene Aihie: Thank you. This is Irene Aihie. We appreciate your participation and 

thoughtful questions. Today's presentation and transcript will be made 

available on the CDH learn webpage at www.fda.gov/training/cdhrlearn by 

Wednesday, June 19. If you have additional questions about today's 

presentation, please use the contract information provided in the slide 

presentation. 

As always, we appreciate your feedback. Following the conclusion of the 

webinar, please complete a short 13-question survey about your FDA, CHDR 

webinar experience. The survey can be found at www.fda.gov /chdrwebinar 

immediately following the conclusion of today's webinar. 

Again, thank you for participating. This conduces today's webinar.

Coordinator: This will conclude today's conference. All parties may disconnect at this time.
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END