NWX-HHS FDA (US)

Moderator: Irene Aihie

11-5-2014/12:30 pm CT

Confirmation # 9036971

Page 1

NWX-HHS FDA (US)

Moderator: Irene Aihie

November 5, 2014

12:30 pm CT

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

listen only mode. Today we’ll only be taking questions by phone, will not be

taking questions by a live meeting. Therefore to ask a question by phone

during our question and answer session you’ll need to press star 1 and record

both your name and company when prompted.

This conference is being recorded. If you have any objections you can

disconnect at this time. And I’d like to turn today’s conference over to Irene

Aihie. Good afternoon. You may begin.

Irene Aihie: Hello and welcome to today’s FDA webinar. I’m Irene Aihie of CDRH’s

office of communication and education. Today we’ll be discussing the final

guidance document titled Distinguishing Medical Device Recalls from

Medical Device Enhancements which published on October 15.

The guidance clarifies for manufacturers how to determine when changes to a

device constitute a recall and when they’re considered a product enhancement.

Today Ron Brown, branch chief in the division of Analysis and Program
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Operation in CDRH’s Office of Compliance will present an overview of the

guidance document.

After his presentation we’ll host a Q&A session during which Ron will be

joined by other CDRH subject matter experts. Now I give you Ron.

Ron Brown: Thank you Irene for that wonderful introduction. So we’ll jump right into our

presentation for today. As Irene mentioned we’re going to be discussing

FDA’s guidance document on distinguishing medical device recalls from

medical device enhancements.

Okay and we’re going to start out with our objectives for today’s discussion.

The objectives for today are ... to emphasize that the key factor in

distinguishing a medical device recall from an enhancement is existence of a

violation of the Food, Drug and Cosmetic Act. We want to ensure that

everyone understands that correctly categorizing a change to a device as a

recall or an enhancement impacts the applicability and nature of industry

responsibilities and the FDA oversight.

We’ll also provide guidance and examples to facilitate the decision-making

process for when a report of correction and removal, also known as an 806

report, to the center for devices in radiological health, and that’s CDRH,

would be necessary.

Okay a little bit of background on why the guidance was created. It’s because

we received some feedback from industry identifying concerns about making

modifications to devices. And basically industry identified they wanted - they 

had concerns with the enhancing of a device caused existing devices to

become violative. Will FDA request a recall if these changes are made? When
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is the change an enhancement and when is it a recall? What needs to be

reported to the FDA?

Our next slide talks about some comments on the draft guidance. There was

request for clarification of definitions, requests for more examples and

clarification of reporting obligations pertaining to medical device reports

of corrections and removals as referenced or as required by 21 CFR part 

806.

Okay our next slide covers recurrent themes that were captured in public

comments on the draft guidance. So some of the identified recurrent themes

were more clarity on what would be considered a stock recovery, asked for an

increase in the number of examples provided, asked to remove the flow chart,

requests to withdraw the guidance, considerations of point of use, appearance

of rule-making. It was identified that it was a subjective and what is the

applicability to future devices as well as does it cover technical violations?

And as identified at the bottom of the slide there were 14 responses and that

contained 111 comments. Okay some key points that we want to identify. This

guidance is intended to clarify when a change to a device constitutes a

medical device recall, distinguish those instances from device enhancements

that do not meet the definition of a medical device recall and clarify reporting

requirements on a medical device reports of correction removal that’s

requirements of 21 (CFR Part 806).

Okay some important factors to be considered. It’s important to note that this

guidance does not alter our current expectations regarding medical device

recalls. It only applies to medical devices regulated by CDRH. Please note

that this rule applies to devices that require or are exempt from premarket
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review. Additionally this guidance seeks to address concerns that firms may

have about making enhancements.

Factors that do not apply, this guidance does not address nor does it apply to

whether or not a new pre-market submission is required. Radiation emitting

electronic product defects or failures to comply with radiation safety

performance standards that are contained in 21 CFR parts 1020 to 1050, nor

does it apply to methodologies for risk management or risk assessment.

Our next slide goes over the recall definition as defined at 21 CFR 7.3(g). A

recall means a firm’s removal or5correction of a marketed device that the

Food and Drug Administration considers to be in violation of the laws it

administers and against which the agency would initiate legal action, example

given seizure. Recall does not include a market withdrawal or stock recovery

nor does it include routine servicing. Additionally, a recall does not include an

enhancement as on by this guidance.

So what is an enhancement? Our next slide has an enhancement definition. A

device enhancement is a change to improve the performance or quality of a

device that is not a change to remedy a violation of the Food, Drug and

Cosmetic Act. Device enhancements include but are not limited to changes

designed to better meet the needs of the user, changes to make the device

easier to manufacture, changes to improve the device’s safety or performance

and changes to the appearance of the device that don’t affect its use.

So, recall identification, things that firms should consider. Is your product a

device? Why are you considering making a change to your device? Are you

currently marketing the device to which you are considering or making

changes?
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Slide 13, what is the violation? I want to re-emphasize that the key factor in

distinguishing a medical device recall from an enhancement is the existence of

a violation of the Food, Drug and Cosmetics Act.

Slide 14 gives some important information on how to help you differentiate

violative devices from non-violative devices. Are the changes intended to

resolve a failure to meet represented specifications or failure of the device to

perform as represented? Is the labeling for the device to which you are

considering making changes also misleading? Does it fail to have adequate

directions for use or does it otherwise violate the Food, Drug and Cosmetics

Act or FDA regulations? Also, you need to consider are you otherwise out of

compliance with FDA regulations.

806 reporting requirements, medical device enhancements do not require the

submission of an 806 report.

Slide 16 talks about other regulatory considerations. Once a determination has

been made, whether the change represents a medical device recall or an

enhancement, additional regulatory obligations should be considered.

So now we’re going to move in to slide 17, that has our first comparison

example and identifies what we’d consider a recall. An In Vitro Diagnostics

or IVD device firm markets a test to detect the level of a specific antigen and

blood. The device represents 95% sensitivity to the specific antigen. Two

years after initial marketing the firm determined that the device sensitivity to

the specific antigen as manufactured had decreased to 90%, thus not meeting

performance specifications and making the device violative.

As a result the firm modifies the product in the field to improve the sensitivity

from 90% to 95%. Because the firm’s actions are returning the product to the
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quality it was represented to possess, FDA would generally consider these

actions a recall.

Slide 18 has a comparison example, what we’d consider an enhancement. An

IVD device firm markets a test to detect the level of a specific antigen in

blood. The device is represented to have 95% sensitivity to the specific

antigen. Two years after initial marketing the firm modifies the product to

improve the sensitivity to the antigen from 95% to 98%. This modification is

determined to be an improvement to the safety and effectiveness of the device

and is determined to be unrelated to any known device violation. FDA will

generally regard this action as a device enhancement although it may require a

regulatory submission.

We’re going to move on to comparison example number two. In our first

example would be a recall or what we’d consider possible recall. Shortly after

launch, the ergonomics of a marketed electro-surgical unit device are

determined to be less than optimal. In that users have reported difficulty

guiding the hand piece and the firm has received reports for serious injury

associated with its use. The firm’s investigation revealed that difficulty

guiding the hand piece contributes to the serious injuries in that the hand piece

is not performing as represented. The firm replaces all the hand pieces in the

field and owns all units currently in inventory, to eliminate the possibility of

serious harm. FDA will generally consider these actions a recall.

Slide 20, we have our ultimate comparison example number two of what was

possibly considered an enhancement. A firm markets a new electro-surgical

unit device. Shortly after launch the ergonomics of the hand piece of the

newly marketed device are determined to be difficult to use. The firm

determines that this difficulty does not change the risk of the device and no

violation of the Food, Drug and Cosmetics Act or regulations are identified.
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The firm develops and incorporates a new hand piece into the electro-surgical

unit device. FDA will generally consider this action to be a device

enhancement although it may require a regulatory submission.

In summary, correctly categorizing medical device recalls and medical device

enhancements amplifies, the likelihood that firms will appropriately determine

when 806 reports to CDRH are and are not necessary and increases the

likelihood that FDA will concur with industry decisions regarding reporting

obligations.

The guidance provides added clarity to regulatory terms and definitions

specific to medical device recalls and enhancements and doesn’t intend to

address the comprehensive obligations related to medical device recalls. This

concludes our presentation and now we will start the question and answer

session.

Coordinator: Thank you. First to ask a question make sure your phone is unmuted. We’re

only taking questions by the phone. We’ll not be taking questions in live

meeting. You’ll see that there’s no Q&A chat box. Now to ask a question by

phone press star 1 and record both your name and company. To withdraw

from the queue you can press star 2. Once again to ask a question by phone

press star 1 and record both your name and your company when prompted.

And our first question comes from (Cynthia Oris) of Phillips. Your line is

open. (Ms. Oris) your line is open. Your phone might be muted. All right our

next question comes from (Mary Lapsevich) of Phillips Medical Systems.

Your line is open. (Ms. Lapsevich) your line is open. (Ms. Lapsevich) can you

hear me? All right one moment please. I’ll see what the issue is. Our next

question comes from Robert Satterfield of Ecaria. Your line is open.
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Robert Satterfield:Yes. I’m hearing that since we actually have an enhancement, if we included

in a regulatory submission and subsequent to that submission there were

problems in the field. Would the post performance in the field, would that

subsequently if deemed appropriate to be a recall even though it was

submitted as an enhancement? Is that possible?

Ron Brown: Hi, I’m sorry. Do you mind repeating the question?

Robert Satterfield:Sure. If we do an enhancement and we do include it in a subsequent

regulatory submission and then after it’s been submitted and the

enhancement’s in the field, if the enhancement is becoming a problematic

situation that’d be deemed to be a recall would it actually be a recall if it was

submitted as an enhancement to the application?

Ron Brown: Okay, thank you for that question and I think I understand the parameters of

the question. Initially you’re saying that your firm determined that you wanted

to take an action that you considered an enhancement and you went forward

and you made changes to the device and you distributed them. And

subsequently your device was determined to be violative due to your device

not performing as represented after this change was made, correct?

Robert Satterfield:That’s correct.

Ron Brown: Okay so there is actually two parts to your question because the initial part of

your question is you had a device that was not considered violative and you

went forward with making a change that fit within the realm of the guidance

document that you identified as enhancement. You documented properly and

you proceeded as we would expect.
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The second part of your question is now you have a violative device on the

market and you need to take action. So then there would be - the second part

of this would be yes, we’ll still want you to follow the guidelines and the

guidance document to say now that you have a violative device on the market

what actions would you take and that’s when you’d make a determination on

whether or not you need to do a recall. Does that answer your question?

Robert Satterfield:Yes it does. Thank you.

Coordinator: Once again to ask a question please press star 1 and record both your name

and company when prompted. And please make sure your phone is un-muted

both when you record your name and company and when your question comes

up and our next question comes from Molly Ray of SoftwareCPR. Your line is

open.

Molly Ray: Yes. The slides of the webinar as well as the guidance document both state

that the guidance is applicable to the medical devices regulated by CDRH. So

my question is, was this an unintentional exclusion of the devices regulated by

CBER or will there be an additional guidance specific to those devices issued?

Ron Brown: So, to answer your question this was a guidance document created by CDRH

with only the consideration of the devices regulated by CDRH and we don’t at

this present time have any intention of putting out another guidance document

in collaboration with CBER and I can’t speak for CBER. At this point in time 

there’s no - a decision hasn’t made been made for CBER to put out a guidance

document but we can verify after this webinar whether or not any of those

actions will be taking place.

Molly Ray: Or is it - is this guidance will also be applicable for those devices?
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Ron Brown: I just want to ensure I clarify. When you say those devices, you mean devices

that are regulated by CBER?

Molly Ray: Correct.

Ron Brown: This device - this guidance document doesn’t apply to those devices. This 

guidance only applies to devices regulated by CDRH.

Molly Ray: Okay thank you.

Ron Brown: You’re welcome.

Coordinator: Our next question comes from Jeff Secunda of AdvaMed. Your line is open.

Jeff Secunda: Thank you and thank you very much for this excellent overview of this

document. I think it’s outstanding that we do now have a clear definition of

enhancements. However, in many places in the document the terms are used

that are confusing such as marketed devices, marketed is a fairly vague term.

In 806 the point is made that devices are distributed which is much clearer.

They’ve left the control of the company whereas marketed could mean that

there are plans to put the device out. Do you have any plans in the future to

make this point clear and to move away from the vague term of marketed

towards something more definitive such as distributed?

Ron Brown: Thank you Jeff for identifying your concern. I think that’s something that

we’ll have to capture and will require further discussion internally to see if

maybe we could provide some additional clarity what we mean by marketed if

it’s something like you’re saying that may cause some confusion.
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Jeff Secunda: Okay thank you. Can I ask one more question? Another term that is used is

clarifying or rather minor violations of the FDNC. This is a good provision.

However will there be out coming guidance on how to define or how to

determine whether a violation is considered minor, not that the FDA could be

taking action? Did you get that part of the question?

Ron Brown: Yes. Could you hold on one second for me Jeff?

Jeff Secunda: Sure.

Ron Brown: Hello Jeff. I understand your concern. I know there have been - we’ve had

several discussions regarding minor violations and I understand the concern

and it’s been expressed by others that industry would like more clarity on

what’d be considered a minor violation. That’s something that I’ll take back

from this webinar to see if that’s something that we could look at making a

possible higher priority but at this point I’m going to have to say that I’m not

sure if we’ll be able to go back and make changes to the guidance but we’ll go

back and re- evaluate to see if we could provide further clarity for industry

regarding those terms.

Jeff Secunda: Very good, thank you very much.

Coordinator: Once again to ask a question press star 1 and record your name and company.

And our next question comes from (Andrew Ecuart) of Johnson & Johnson.

Your line is open.

(Andrew Ecuart): Thank you. First question, would we have access to these slides? Hello?
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Ron Brown: Yes. I’m sorry. The slides are posted. If you look at the last slide -- number 22

here -- it shows where it has the information about the slide presentation,

transcript and webinar recording will be available.

(Andrew Ecuart): Thanks. My other question is I think in most of the examples you gave, I’m

going by memory. The one that were called recall had within the element of

making a correction of products in the field as well as a new release product.

I’m not sure how much of a significance that has on it because a lot of the

time it’s subtle to determine if something is violative.

And what I mean by that is you may have a certain compliant in the field and

it’s not a one to one root cause but you determine that you can make an

enhancement maybe like you handle example where you can make a device a

little bit easier to use and you make that enhancement of future products, of

products that are still in your control or future manufactured products but you

don’t change anything in the field. Does that have any bearing on whether we

consider enhancement or recall?

Ron Brown: So, I think that’s a very good question and I think that is in line with what

we’ve had in our examples because you’re talking about something that may

not be considered violative and if it’s not something that you’d consider

violative and you’re making a change, I think that’d be something that we’d

consider, would be an enhancement.

But that’s going to be based on your evaluation because I think that, of course,

we were only allowed to share so much information because webinars have a

limited number of slides. But there’s information in the guidance document

that really clearly defines or adds more definition of what we’d consider

something being violative.
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So some of the things that you’re talking about is whether it’s a one time issue

versus some trending and some other things that may be identified. I think that

you have to really closely evaluate that yourself and to see what the

significance of it is. And if it’s something minor like you’re saying, like the

hand piece changed, that you’re saying there’s not anything that’d be

considered a violation. Then I’d say that I’d feel comfortable with going

forward, proceeding and documenting it properly.

(Andrew Ecuart): Okay thank you Mr. Brown.

Ron Brown: You’re welcome.

Coordinator: And our next question comes from (Robin Thasener) of Esculop. Your line is

open.

(Robin Thasener): Yes thank you. I had the same question about minor violation so I think you

already addressed that. Thank you.

Coordinator: Once again to withdraw from our queue you can press star 2. To ask a

question by phone press star 1 and record your name and company. And our

next question comes from Madubuike Okafor of Orthozon Technologies.

Your line is open.

Madubuike Okafor: Yes hello. The first product comparison number one, part one, where the

company improved the sensitivity to match what was actually advertised on

the label. You called this a recall but you didn’t actually go into whether or

not they - would they have to have withdrawn it from the market or did they

just have to improve the sensitivity of newer products that they began to

distribute. Was it recalled? Was it physically actually recalled from the

market, distributors and everything?
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Ron Brown: Okay, so thank you for that question and I just want to point out first and

foremost that these are hypothetical examples so there aren’t any - there

weren’t any actual actions taken. But if you’re really asking I guess about

expectations -

Madubuike Okafor: I understand. I understand they’re hypothetical but I just think or make

sure that I orient myself and understand what exactly was - you’re trying to

get across. I just want to understand it. Are you calling it a - in order for it to

be a recall do they actually have to - in this hypothetical situation did it

actually have to be removed from the shelves or was it - hypothetically was it

okay for them to just increase the sensitivity?

Ron Brown: Hypothetically, I think what you’re really asking is what are the FDA’s 

expectations for this hypothetical example. And if it’s a violative product

that’s on the market and you’re going to make this change this should be one

of those situations where I think firms should consider performing a removal

and then the product that has been improved to meet the represented - the

specifications that were identified when this product was cleared, should be

distributed as a replacement product.

Madubuike Okafor: Okay, so it should be what as a replacement product? Advertised as a

replacement product?

Ron Brown: No. I’m sorry. I’m just going to take a step back and just go through recall

process here because this is more of a recall process type of question. So a 

recall is - could be a correction or removal and for a medical device recalls,

particularly IVDs, there may be two parts to this action that may take place.

And, so you have a device that’s violative- so you have a device that’s
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violative. You have to make a determination whether or not the device needs

to be corrected or a removal.

So, in some cases a correction may be a short term fix where you’ve identified

a customer that this labeling - this error, maybe you need to bring this to your

attention and your customer notification that we’re going to replace.

So please quarantine your products to be recalled and we’ll send replacement

devices. And that’s something that your firm will have to identify in your

recall strategy but the expectation is that if you have a violative device on the

market, that you should cease distribution and in most cases remove the

product and replace it with a product that is not violative.

Madubuike Okafor: Okay.

Ron Brown: All right, the next one.

Coordinator: And our next question comes from Michael Fales of GE. Your line is open.

Michael Fales: Hello guys, appreciate you having this. This is very informative. We - again

industry thanks you, I have a question regarding cyber security vulnerability

and what your position would be regarding that.

The example would be that the device itself doesn’t actually have a defect in it

but it does have a vulnerability and we’re able to partner with maybe the

software suppliers, got a couple of them that were pretty well known this year,

heart bleed and shell shock which impacted a number of companies’ products.

And when we actually go to the fields to improve and apply patches to

improve the vulnerabilities, will this fall under the enhancement paradigm that

you’ve described.
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Ron Brown: Okay. I’m going to have to defer you for this question to the cyber security

guidance. And we have - if you look at the slide on the screen for questions

regarding - some more general questions that aren’t specific to the guidance

there’s a link to notify a division of industry and consumer education also

known as DICE and the link is provided. I’d have to refer you to them so they

can give you a copy of that guidance document to help you with this question.

Michael Fales: Thank you.

Coordinator: Our next question comes from Steven Sorge of GE Healthcare. Your line is

open.

Steven Sorge: Hello. I had a question about the slide deck to find a device enhancement

number one a change to improve the performance or quality of the device. So

I guess we’re saying conversely that if it’s not that we want to consider that a

recall. In the context of this guidance when I think about 806 and the section

806.10 versus 806.20, are we talking about both of those categories of those 

field actions or just the reportable category?

Ron Brown: Thank you for that question and I just want to try to repeat the question to

make sure that I understand and other people on the phone understand it. So

your basic question is you’re identifying that, in 806, there are some different

reporting obligations whether it’s within the realm of 806.10 versus 806.20.

And you’re asking whether or not those things come into play when you’re

trying to make a decision of whether it’s a recall versus an enhancement.

I’ll like to say that I think that if you start going down that path I think you’re

going a little bit too far because what we’re really considering is whether or
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not it fits into the realm of 806.10 or 806.20. That’s still within the realm of a

recall and 806 just states what are the reporting obligations versus whether -

it’s not getting into whether or not it’s a recall. At that point in time you

already know it’s a recall. It’s just whether or not you have to report 806. So

the guidance is saying that regardless of if you put in that framework of

enhancement versus a recall, the 806 aspect doesn’t have as much weight as 

far as the reporting obligation.

So in summary and what I’m trying to really get to my point here is, those

things don’t necessarily have weight on whether or not it’s a recall versus

enhancement because anytime you’re at that point where you’re saying I’m

trying to decide if it’s 806.10 or 806.20. You’ve already decided that it’s a

recall and you’re trying to decide whether or not you need to report it.

Steven Sorge: yep, Great. Thank you. That helps a lot.

Ron Brown: You’re welcome.

Coordinator: And our next question comes from Mr. Weiping Zhong also of GE

Healthcare. Your line is open.

Weiping Zhong: Hello, thank you Ron. This is great. I have a question regarding page 11. You

have - you define the enhancement as to - let's say you change it to make the

device safety like equal the safety. So my question would be during the premarkets let’s say you identified some risks and you present in the 510k 

submission and then when the product is in the field, you have a standard.

Now you can make some improvements to let's say eliminate those risks or

reduce the risk. Would that be treated as a recall or improvements?
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Ron Brown: I have to apologize. I didn’t hear part of your question and I'm wondering if 

you'd mind repeating it please.

Weiping Zhong: Okay. On page 11 on the definition of enhancements, part of it is to make the

device easier and the changes to improve the safety during the 510k, let’s say

I identified in the device, let’s say one of the chips will fail and this failure of

the chips will cause certain hazards. And that was cleared in the 510k process, 

and when the product is in the field, they observed the complaints about failed

components that are the chips. If it’s expected or predictive before we release

a product but now with the technology improvements, we have newer chips

that can replace that, let's say, and then improve the safety, as by doing it

would it become a recall?

Ron Brown: Thank you for that question. And I think I - thank you for repeating the

question. I think I have a better idea of what your basic question boils down

to, is do you need to consider this device as a recall or as an enhancement and

what will be the rationale for it.

And I think that based on that information that you provided to me it sounds

like early on in your process you identified some possible complaints or some

identified problems in your manufacturing that may identify your product as

being (violative). And if that’s the case then I’d say that yes, you’d need to

look at how this fits into the paradigm of whether or not it’s a - what we call

recall action.

Weiping Zhong: Okay thanks. Yes I think the difficulty was if you have the baseline safety

which was cleared by FDA and then the (unintelligible) to (unintelligible)

show that it’s truly there as (unintelligible). But I guess probably it's case by 

case based on your answer.
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The other question I have is let’s say you’ve identified a new use cases out of

(users in the field), right? And then most new use cases could become - in

some cases could have some risks there and now you want to communicate

with the users and saying by doing this and by doing that it may not be good,

only be good. So would that be taken as a recall or enhancements?

Ron Brown: So I want to make sure that I clearly understand your question. When you’re

saying there’s new used cases are you saying that - I want to stop here and just

turn to a certain segment of the guidance document to ensure that I’m

following your question. And really what we’re talking about here is

differentiating violative devices from non-violative devices.

And so on page 6 of the guidance document one of the things this point out is

- and it sounds like what you’re referring to here, is an increase in overall

failure rate, increase in a single failure mode rate or an indication of a new

failure mode. It may suggest a failure as a device to perform as represented.

And those are some things that - it sounds like in your examples that you may

be eluding to and if I’m not in the right area of concern can you please let me

know right now? That’s kind of like what you’re referring to?

Weiping Zhong: I think when you said the new used cases I think you’re right. Could it be a

new failure mode? I think it’s a good answer. Thank you very much.

Ron Brown: All right, you’re welcome.

Coordinator: Once again to ask a question press star 1 and record your name and company.

And our next question comes from (Lawrence Pitchiano) of Johnson &

Johnson. Sir your line is open.
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(Lawrence Pitchiano):Thanks very much for the presentation today and excellent question and

answer session. My question has to do with the first set of examples with

regard to IVD performance change and consideration for pre-market

notification that’d be a submission. So in the latter case example where the

enhancement was made from 95 to 98% sensitivity there was a specific

comment there to consider the need for a notification, some kind of

submission.

Now with regard to the violativ edevice that was being restored from 90 to 95

are we still going under prior guidance which is if you’re restoring the product

to its original state? And so in the case of an IVD if it was a reformulation or a

tweak in the algorithm to restore the sensitivity that wouldn’t require a

submission or is that same thing changed since the issuance of this guidance?

(Ian Fletcher): My name is (Ian Pilcher) and I’m a consumer safety officer in OIR for In 

Vitro diagnostics. There are kind-of two parts to your question and there are

two different criterias to whether you get a new 510K. Since you’re just

restoring it to clear performance there’s no performance change and based on

that, you wouldn’t require 510K. It’s going to depend on what change you’re

making. If it is a must then you have to look at the other half and are you

changing your product, your technology in a significant way.

If it’s a minor change to an algorithm, algorithms are touchy so we’re going to

kind of not touchy. They’re difficult because it depends on how they’re used

and what role they play in the device that if you were changing a buffer or

making some minor change like that it wouldn’t require a 510K. If you were

making a larger change to this essay of the device or the reagent, the

instrument or the reagent, that may require a 510K. So you’d have walk

through that guidance and determine whether or not a new submission is

required.
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(Lawrence Pitchiano):Okay thank you. I appreciate it.

(Ian Fletcher): You’re welcome.

Coordinator: And our next question comes from Earle Canty of Intuitive Surgical. Your

line is open.

Earle Canty: Thank you very much for the opportunity to ask this question. The example is

you have a device in the market. You have no reports of serious injury. The

device meets specifications and it’s acceptable from your risk management

process. You identify and develop some enhancements to that. The

enhancements reduce risk. We’d argue that that’s an enhancement and not a

recall. Would you concur with that assessment?

Ron Brown: Based on what you’re saying and to do a quick summary of what you’re

saying is you have a device that isn’t (violative). You’re looking at making

some changes in the device that aren’t as a result of the device being violative 

for any risk of being previous identify. And the changes were actually are

going to - changes are going to improve the device’s safety of performance is

what - it sounds like you’re saying.

Earle Canty: That’s correct. Risks were identified but they were deemed acceptable. And so

the change is further reducing the likelihood of that risk.

Ron Brown: And it sounds like it’s within the realm of what we’ve listed on - in the

enhancement definition on page 11 when you were just talking about a change

to improve device’s safety performance. It’s not a change to remedy a

violation of the Food, Drug and Cosmetic Act.
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Earle Canty: Thank you very much.

Ron Brown: You’re welcome.

Coordinator: Once again to ask a question press star 1 and record your name and company.

And our next question comes from (Ashley Davis) of (Turmo) DCT. Your

line is open.

(Ashley Davis): Thank you. When considering software bug fixes when does the agency

consider its software bug fixed to be an enhancement and can any bug fix

being applied to a device currently in distribution as well as to further

production be considered an enhancement?

Ron Brown: Thank you for that question. Again can I ask you to - let’s go back to the first

question. That might make it easier and better for the audience for me to -

when I go to respond to make sure I identify exactly what you’re asking. I

think the first question you were talking about there was a software correction

that needed to be made.

(Ashley Davis): My question really was when does the agency consider its software bug fixed

to be an enhancement?

Ron Brown: So we do have - give me one second please. I want to make sure I can point

you in the right direction. I know we do have an example in the guidance

document that talks about software. Thank you. We do have an example in the

guidance document on page 6 where it talks about medical device software.

And basically I think you’re challenging the fact that we have an example that

talks about what we consider the software change to being a recall and are
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there examples of software fixes where it could be considered an

enhancement.

I’d say that there probably are if they’re within the realm of the device not

being violative because there may be some instant changes you’re going to

make based upon user request that may be minor things like we have an

example where the device has changed and the display on the device was

changed to make it easier for the end user to see the information being

displayed. So there are some changes that I think will fit into that realm.

However I can’t give you any examples right now off the top of my head.

(Ashley Davis): Okay thank you. My second part of that question is can any bug fix being

applied to the device is currently in distribution as well as to future production

be considered an enhancement? So it’s already out in the field as well as still

in-house.

Ron Brown: I’m sorry. Can you repeat that question?

(Ashley Davis): Can any bug fix being applied to devices currently in distribution as well as to

future production be considered as an enhancement?

Ron Brown: So if you’re making a change to newly produced products as well as products

out on the market that aren’t violative and it fits within that definition of an

enhancement then the answer is yes.

(Ashley Davis): Okay thank you very much.

Coordinator: Our next question comes from Mr. Tom Shafer of Stryker Endoscopy. Your

line is open.
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Woman: Hello. Thank you for taking our question. I’ve got a question on stock

recovery. We (unintelligible) of the definition of stock recovery you talked

about marketed but the example that you guys have given in the guidance

document talks about distributing product from the non-conforming 

(unintelligible). So is that - would that be the guidance going forward on stock

recovery? We haven’t - that we have marketed the product but we haven’t

distributed it. Would that be considered stock recovery?

Ron Brown: So the key point for a stock recovery is that no portion of the product has been

released. Everything is still under the firm’s control. So if the devices are still

under your control then it would fit into the realm of a stock recovery.

Woman: Correct. But my question is that we have marketed the device but the device

that’s not in our control is not (violative). But based on this issue during

manufacturing only that lot was affected, not everything that’s out in the

market and all of that lot which was non-confirming or had the issue was still

in our control and we decided to fix that lot. Would that fall under stock

recovery?

Ron Brown: So thank you for that question. So I think I have a good idea of what you’re

saying. So basically the products that were previously distributed weren’t

(violative). You discovered a problem in manufacturing with the lot that

hasn’t been released. And so what you want to know is since it’s still under

your control would that be considered a stock recovery.

Woman: Correct.

Ron Brown: Okay. So that sounds like its well within the realm of a stock recovery. But I

think FDA does want you to ensure that these devices have been distributed
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wouldn’t have to worry about the same issue of concern being identified with

the products - the same products that are part of the stock recovery.

Woman: All right. Thank you. I actually have another question on software

modification. So like I said we do have - started looking at the example that’s

in the guidance document.

Let’s say we have, you know, an issue in the field, and we’re getting

complaints about it but that figure mode has been identified in our risk

document and is well within the entry that we’re seeing. It was going to occur

in the field but we still decided to take an action and upgrade our software to

reduce the (unintelligible) mode. Would that be considered enhancement or a

recall if we did decide to do anything with the product that was on the market?

Ron Brown: So the basic question is would this be - would your device be considered

violative if it’s still within your expectation of failure mode in rate, correct?

Woman: Correct.

Ron Brown: Well if it’s still within the realm of what’s the expected for your failure mode

in rate it sounds like the device may not be considered (violative). However, 

FDA also caution firms that sometimes when they do look at what they’ve had

as parameters from the point of design and they’ve been distributing the

product for several years they need to go back and make sure they’re reevaluating that because there are some significant single failure modes that

FDA would be very concerned about. So that’s something that I’d caution,

that sometimes when firms are doing the trend analysis they may say for the

month we’ve had ten failures.
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However you had three failures so very significant and they were very high

risk to the patient. And you haven’t had - and you may have ten for this month

and you may have one for January, two for February and you average them

out and you’re well within your parameters of what you’d consider average

failure mode.

So that’s something that I think you should really take some time and consider

when you’re evaluating what’d be considered accessible as far as failure mode

and rate and you’re doing your trend analysis.

Woman: All right. Thank you so much. That answered my questions.

Coordinator: And our next question comes from either (Rachel Weiss) or (Cathy Park) of

(Michael Ford) Orthopedics. Your line is open.

Woman: That’s MicroPort Orthopedics and thank you for taking our question. I

understand under the guidelines as it’s stated now that we don’t have to

submit an 806 for an enhancement. If our company decides that we all agree

this falls under an enhancement what evidence do we need to maintain that

we’ve made that decision? Where would we keep it and how long or do we

even need to do it?

Ron Brown: Hopefully so. I’d say - I’m sorry. So I think that the basic question is do you

need to maintain some documentation and that’s yes because when FDA

investigators come out they’ll be looking at your records and they’ll be

looking at things where you decide if this was or wasn’t a recall, whether or

not something was reportable for an 806 and if you have justifications in that

reporting and whether or not like you’re saying if it’s an enhancement how are

you identifying that this doesn’t fit within the realm of being a recall.
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Woman: So is that captured on an 806 form or can each company create their own type

of documentation?

Ron Brown: So at this state we don’t have any standard format for documenting this

information. It’s not captured for 806 because we’re saying that it’s exempt

from 806 reporting. So that’s something that firms will have to ensure that

they document as they would all of their decisions.

Woman: Okay. Thank you very much.

Woman: Do we want to - no. I think the rest of our questions have been answered

previously but thank you.

Coordinator: Once again to ask a question press star 1, record your name and company.

And our next question is a follow up question from Jeff Secunda of AdvaMed.

Your line is open.

Jeff Secunda: Thanks for taking this follow up. This is in regards to changes to the label or

labeling in a situation where a company becomes aware that customers are

using the products incorrectly despite adequate instructions. And they send a

letter to customers saying basically read the instructions. They tell you what

you have to do. That’s one scenario.

The other is where the company provides additional information in a letter,

additional information that wasn’t in the instructions for use but is simply to

use the term an enhancement of the information that the customer could use.

Are those enhancements or are they considered to be recalls?

Ron Brown: Okay thank you for the question. I want to just stop here and just to make sure

I identify each scenario separately. So the first scenario, it sounds like you’re
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saying that devices not (violative), what you’re doing is sending out a form of

communication reiterating to customers that you have concerns that they’re

not following the instructions for use and maybe using the device off the label.

In that case then you - then firms are within the right to just issue that

communication. And generally that’s in the realm of what we’d consider a

safety alert where there’s no violation. Firms are basically reiterating what’s

already in their labeling.

Jeff Secunda: Okay.

Ron Brown: And if you don’t mind could you go through the second scenario again?

Jeff Secunda: Sure. The second scenario is where the company provides additional

information to support the state methods already in the IFUs. So the company

wouldn’t consider the labeling to be inadequate or violative but it’s to help the

customer better understand a certain issue so this additional information not

just reiterating existing information.

Ron Brown: I hesitate to give you a blanket answer of this sounding like an enhancement

because I have to be honest, the example is a little vague to me in what

information is being added to the IFU. Anytime you make changes to the IFU

FDA is concerned that there’s possible relabeling which fits into the realm of

what’d be considered a correction.

So I think you have to evaluate what - how significant those changes are but

I’d say that at this point in time this would be another opportunity to point out

that if you have questions like this and you’re looking at making these types

of changes I’d refer you to dDICE as I mentioned earlier. Their information is
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on this last slide and they can help you in trying to - to get into maybe some

specifics of what the changes you’re intending to make.

Jeff Secunda: Right. I understand the difficulty in - especially in the second scenario. Does

FDA have any plans to have additional guidance so that companies would

know when a safety alert is -- if you will -- an enhancement and when it

crosses the line into a correction?

Ron Brown: At this point in time, we don’t have anything we’re working on as far as

guidance document or anything that’s for a safety alert but that’s something

that we’ll definitely take back as an identified concern of an area that’s of

interest. We have - that concern has been expressed before and I’m glad you

shared that so we can make sure that we need to maybe take a look at going

back and adding some more emphasis possibly in this area.

Jeff Secunda: Okay. Thank you very much.

Coordinator: Our next question comes from (Patricia Lee) of Thermo Fisher Scientific.

Your line is open.

(Patricia Lee): Hello. Once you determine you need to go down the path of recall for a

violative product what’s considered the data’s initiation for the recall, the date

you send the letter out or the date a customer receives the notification?

Ron Brown: So - I’m sorry. Could you repeat your question?

(Patricia Lee): Once you decide that you need to initiate a recall is the initiation date the date

you send out the letter or is the date the customer receives the notification?
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Ron Brown: So the basic answer to your question is when you send out the letter to notify

the customers, that is a point in time where it’d be considered you’re initiating

a recall.

(Patricia Lee): Okay thank you.

Coordinator: And I show no further questions at this time.

Ron Brown: Can I just - just one last point, that last question. I also want - would you like

to consider that for recall initiation there’s some other areas of concern that

I’d like to share that were not mentioned in your question. So additionally if, 

within your firm, at the point of time when you decide and whoever has the

authority to make the final decision of whether or not to recall, once that takes

place that’s when we’d consider one example of recall initiation.

A second example is as you’ve mentioned, when you issue the letter. A third

example would be if you actually take an action of removing a device a

performance in former correction. So I just want to make sure that we give

you a little bit more information that may be helpful when you’re trying to

decide when a recall has initiated and especially when you’re trying to meet

the ten working days requirements for 806 report.

Coordinator: And (Ms. Lee) if you need to have a follow up.

(Patricia Lee): No thank you.

Coordinator: All right. We do have one other question from Kevin Randall of

ComplianceAcuity. Your line is open.
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Kevin Randall: Yes, thank you for taking my question and taking the time to answer and put

the guidance document together and discuss this difficult (process). So over

the preamble to FDA’s quality system regulation in part 820 the FDA says

that user error is considered to be a non-conformity. I’m wondering when user

errors then trigger the threshold of being violative or making the product

(violative).

Ron Brown: So I’d have to hesitate at this point in time because I - this is outside - I’m

sorry. Your question is outside the scope of the guidance and I’m not prepared

to answer that question.

Kevin Randall: Well maybe I can rephrase it. If we have discovered user error in the

marketplace what should we be doing to decide if that constitutes a

(violative), makes the product violative such that we’d need to do a recall?

Ron Brown: So user error - there’s a couple of things to consider when we start talking

about user error. And one of the things that you’ll see in the guidance

document also talks about labeling concerns and whether or not it’s adequate.

So when we start talking about user error and when I go out and do

presentations with the firms we get into some discussions of root cause

evaluation.

So when you’re doing a root cause evaluation I caution that sometimes people

get into the realm of user error and it’s usually identifiable as a root cause but

I’d caution and say maybe take a deeper dive to ensure that there may not be

some other concerns that may be the true cause whether it’s inadequate

labeling, whether it’s even within the main - on the manufacturing plant floor

where you have your SOPs are inadequate.
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There are so many things that may come into play when you start talking

about user error so there’s the intentional - unintentional mistakes and with

device labeling. So those are some things that you may want to refer to when

you’re considering user error.

Kevin Randall: Okay thank you.

Coordinator: Our next question comes from Greg Levine of Ropes & Gray. Your line is

open.

Gregory Levine: Yes hello. Thank you very much for the program. I’m trying to understand the

scope of FDA’s assertion that identifying a new failure mode is a recall.

So if you have a problem that you find post market and that wasn’t readily

foreseen pre-market when you did your risk analysis you issue a

communication to users to inform them of this issue and how they might

protect the patients against this problem and let’s say that perhaps it wasn’t

foreseeable because it only affects only a small sub-population of the users.

So you’ve issued these in a notice like a safety notice and this isn’t

information that’s already in the IFU. Its new information for the users and it

is reduced in the risk to health at least in this particular sub-population. Is that

a recall in FDA’s view and if so why is that a recall because I think - and also

assume the company never made any specific assertions or promoted the

product for use in this particular sub-population so something that wasn’t

initially foreseen. So could you address whether that type of circumstance

would be a recall?

Ron Brown: So you added a lot of variables in that examples that make this question a little

bit difficult to answer especially at the end where you alluded to all label use.
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Gregory Levine: Okay, sorry. I didn’t mean to allude to all labels. I was just trying to say that

the manufacturer never specifically promoted the device as particularly useful

in a given sub-population, the sub-population for which the failure mode was

later identified. So it was just that it was intended for a general population and

then later post-market they identified that there is a problem with the device in

a particular sub-population.

Ron Brown: There’s two parts to this question that does - that I want to address. So the first

part was you mentioned that FDA sees a failure in a single failure mode at

every instance as a recall and that’s not true. I just want to make sure that you

understand that this is something we want you to evaluate when you’re trying

to make your decision.

We don’t think that every time that there’s a single failure or a new single

failure mode that fits with the requirement of a recall. And the second thing is

there are some intricacies in your example that will require more delving into

to be able to make a determination whether or not your device is violative 

because based on your example it’s hard for me to discern whether or not it’s

violative.

It sounds like your IFU is correct and it sounds like the patient population.

Here’s where it gets tricky when you get for general population but you say

it’s not intended population. So that to me is it gets a little confusing when

you say it’s for the general population because that means that includes

everyone. So when you say that was intended for that population that

statement is a little contradictory to me.

So that statement alone makes me - gives the appearance that the device may

be considered violative because you did have that in your IFU and it was
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indicated by your firm and your labeling that it’s okay for users to - for that

population to utilize that device and that should’ve been I think considered in

your risk evaluation. And that’s something that we may consider it a recall

because you’re going out and you’re doing a formal correction to reduce the

risk to health.

Gregory Levine: I apologize, thanks. I was probably a little unclear on that point and I may

have thrown you. I don’t mean a general population as in everyone in the

universe. I mean that the device is cleared for a - a device has an intended use.

That intended use doesn’t specify particular ages or particular types of

patients with particular conditions and so on. It just says it’s useful for patients

who have particular disease or condition in general. If you have this disease or

condition the device is useful for you.

Post market what you learn is that a small subset of patients who have

particular characteristics, that there’s a - the device doesn’t perform optimally

in those patients. And so there’s a - I think our (arguably) a new failure mode

you’ve identified a failure mode you didn’t enforce initially when you did

your risk analysis. I think you answered my question when you said - you may

have answered my question when you said not every identification of a new

failure mode is a recall because one I think could potentially read the guidance

to suggest that.

You’re saying that’s not the case but I didn’t mean to suggest that there was

something off label about the promotion or use of the device. It’s all on label.

The issue is post market you identify a problem in a given subpopulation and

then you put out information to tell users, tell the physicians if you have

patients who have these attributes you should be aware of this issue.
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Ron Brown: So I - if this situation were presented to me with more specific information, it

sounds to me like on the surface that you are performing some form of

correction to reduce the risk to health and it sounds like your device may be

considered (violative).

So I’d say that if you weren’t sure in this situation I’d definitely caution you

to reach out to your local district office. And if you’re not familiar with that

person we do have that information on slide 22 so you can access that

information and I’m not eluding to this is something that you may have an

actual scenario but this is something that you may want to reach out to them

directly if this type of situation does occur.

Gregory Levine: Thank you.

Coordinator: Our next question comes from (Cathy Park) of MicroPort Orthopedics. Your

line is open.

(Cathy Park): Thank you. We have another question involving the enhancement portion.

This enhancement only concerns the final device. Say we were to change

something in the process, a different machine, a better machine but the final

design and product was the same. That wouldn’t fall under an enhancement,

correct?

Ron Brown: So enhancement definition, it does talk about changes to make the device

easier to manufacture. Is this the case that you’re alluding to in your question?

(Cathy Park): Easier to - not necessarily, like I said a new machine. Easier to manufacture,

I’d interpret that we cut a step out or we done something to the product to

make easier to assemble which to me would mean you’d have to change the
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prints, etc so no. I’m talking about if we just changed the manufacturing

machine for instance.

Ron Brown: So the device is still performing as represented.

(Cathy Park): Correct.

Ron Brown: It’s still manufactured the correct specifications.

(Cathy Park): Correct.

Ron Brown: So your basic question is whether or not this would be an enhancement. I

don’t think is really an enhancement question. I think this is what other

regular obligations you need to consider because the device is not (violative).

So you’re not making the change to the actual device. You’re talking about

manufacturing process changes where it may move in more in the direction of

possibly 820 considerations.

(Cathy Park): Yes, perfect. Okay thank you.

Coordinator: Our next question comes from (Kara Shapiro) of Johnson & Johnson. Your

line is open.

(Kara Shapiro): Hello. I have a question about if we had a case where we had products that

was distributed and was acceptable for our internal risk documentation and

then we had some product that had not been distributed and was held for an

investigation for some other reason but for the product that was still under our

control. If we sound that it was acceptable for our documentation but had a

higher potential or poor potential performance. And in an effort to be as

conservative as possible we wanted to scrap that product.
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Even though both these groups, what was in our control and what had already

been distributed met the same requirement, would scrapping the product that

hadn’t been distributed put us in need of recalling or otherwise affecting the

products that was in the field?

Ron Brown: Okay so the basic premise of your question sounds like it’s along the lines of

what we discussed earlier regarding a stock recovery because you have some

devices that are in your stock and you identified that wait a minute, these

devices may not be performing as represented so you want to take action on

those. And you want to know whether FDA would expect you to take action

on the other devices that are out or have been distributed.

(Kara Shapiro): That’s correct.

Ron Brown: And the answer is yes because these devices should be considered if they’re

manufactured at the same time. They should all have the same actions taken.

Customers should be notified and you should take action to remove the

devices from the market.

(Kara Shapiro): Okay and that’s even if they’re all meeting our internal documentation

meaning our internal acceptable risk levels.

Ron Brown: So I think what we’re talking about here is a couple of things. Basically firms,

they have products that release in the market. They have products that they

may have in this document but they also generally - some firms maintain

additional products for additional testing to ensure that the products on the

market are still meeting specifications. And so sometimes that’s when some of

these things are detected.
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They continue doing their internal testing products that would fail. And in

those cases sometimes new issues are identified that may not have been

discovered in the product release testing. So yes, we do expect or, yes, we

expect firms to take actions to ensure that the violative products are removed

from the market.

(Kara Shapiro): All right, thank you.

Coordinator: Our next question and apologies for the pronunciation is (Anya Silmer) of

Trigger Medical. Your line is open.

(Anya Silmer): Good afternoon and on page 6 of the guideline there - it’s distinctive that

failure to perform (unintelligible) will generally constitute a medical device

recall. And my question is then how would (unintelligible) specification is

defined if this is covering only the specifications given to the customer and in

the (accordance) of international (unintelligible) or if this includes all internal

manufacturer specifications.

Ron Brown: I’m sorry. Could you repeat your question because I want to make sure I

understand. It almost sounds like there are two parts to your question.

(Anya Silmer): Okay. On page six of the regulation it’s stated that the presented specifications

that failure to perform according to (unintelligible) specifications would

generally constitute a medical device recall. My question is regarding the

definition of represented specification, does this include only specification

(unintelligible) to a customer and according to international regulations or if

this is also applicable to internal device manufacturer specifications which

may be in the level above the required specification?
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Ron Brown: So I think the basic question is - what we’re talking about here is what we

mean by the represented specifications. And so the represented specifications

are going to go back to what are the specifications that you have identified in

your IFU. You have identified in your pre-marked review anything that

you’ve identified as what are the specifications for your device.

So when you send your device in for pre-marked review you’re identifying

specifications and you’re identifying how the device is expected to perform.

So when it falls outside those parameters that’s when you’ll want to consider

whether or not your device is (violative). Does that help answer your

question?

(Anya Silmer): Okay thank you for that.

Coordinator: Our next question comes from (Laura Lee Mylicon) of Medtronic. This is our

last question. Your line is open.

Man: Hello this is (unintelligible) early but the question is in 806.2 in the definition

of correction it was the term point of use. In your guidance the point of use

term has been removed. I want to understand the implication of that change. If

we apply the term point of use it may imply that we do design changes on

upstream and future products but don’t change products that are existing in the

field. Then that could be considered not a correction. Is that correct

interpretation?

Ron Brown: So basic answer to your question is - and I want to make sure I summarize

things correctly. I think the basic answer to your question is if you make a

change to your device and you only make changes in devices that haven’t

been distributed and you’re going to make - you’re not going to do any

correction or removals to devices that have been distributed. Is that within the
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realm of what we consider acceptable or would it fall into the realm of

reportable correction. Is that what you’re asking?

Man: A correction, could be a (unintelligible) or not a (unintelligible), yes.

Ron Brown: Yes so the basic concern is, and you’re asking why the definition from the

guidance document - the 806 definition isn’t referenced, the part 7 definition

is referenced because the basic expectation is, if you have violative products

on the market, FDA does expect you to address those violative products.

Man: Okay. So the point of use definition needs to be included when we define a

correction or not?

Ron Brown: The point of use definition wasn’t included in the guidance document and that

was - it would refer to the definition in part 7 to outline our clear expectations.

Man: Okay thank you.

Coordinator: That concludes our question and answer session. And I’ll turn the call back

over to the moderator for the close.

Irene Aihie: Thank you. We do apologize as we’ve run out of time during today’s Q&A

portion of today’s presentation. If you have any further questions please send

them to DICE@fda.hhs.gov. Again this is Irene Aihie and we appreciate your

participation and thoughtful questions.

Today’s presentation along with the slide presentation will be available on the

CDRH Learn section of fda.gov and also at www.fda.gov/cdrhwebinar by

Friday November 14 under the tab “past webinars and stakeholder calls

2014”. If you have additional questions about the guidance please use the
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contact information provided at the end of the slide presentation. As always

we appreciate your feedback. Again thank you for participating and this

concludes today’s webinar.

Coordinator: That concludes today’s conference. Thank you for your participation. All

participants may now disconnect.

END