FDA Webinar

Moderator: Irene Aihie

11-01-18/3:00 pm ET

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FDA Webinar: Benefit-Risk Factors to Consider When Determining Substantial 

Equivalence in Premarket Notifications (510(k)) with Different 

Technological Characteristics: Final Guidance

Moderator: Irene Aihie

November 1, 2018

3:00 pm ET

Coordinator: Welcome and thank you for standing by. All participants will be in listenonly mode until the question-and-answer session. At that time please press 

star followed by the number 1 to ask a question.

Today’s conference is being recorded. If you have any objections, you may 

disconnect at this time. I’d now like to turn the call over to your host, Irene 

Aihie. You may begin.

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

Office of Communication and Education. On September 25th, the FDA issued 

the Final Guidance, Benefit-Risk Factors to Consider When Determining 

Substantial Equivalence in Premarket Notifications (510(k)) with Different 

Technological Characteristics. The goal of the guidance document is highlight 

factors the FDA considers when evaluating benefits and risks of a new device 

compared to a predicate device during a 510(k) review when the FDA has 

determined that the intended use of the device is the same, but there are 

different technological characteristics.
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Today, Ifeanyi Uwemedimo, Biomedical Engineer, here in CDRH, will 

present an overview of the guidance document. Following the presentation, 

we will open the line for your questions related to information provided 

during the presentation. Additionally, there are other Center subject matter 

experts here with us today to assist with the Q&A portion of our webinar. 

Now, I give you Ifeanyi...

Ifeanyi Uwemedimo: Good afternoon. Thank you Irene for the introduction. As Irene noted, 

my name is Ifeanyi Uwemedimo and thank you all for attending today’s 

Webinar on the 510(k) benefit-risk guidance. 

The official guidance title is Benefit Risk Factors to Consider When 

Determining Substantial Equivalence in Premarket Notifications with 

Different Technological Characteristics.

The objective of today’s training is to understand the purpose of the guidance 

and the policy specified within the guidance. We also want FDA staff and 

industry to understand when a benefit risk assessment is recommended in a 

510(k), how the guidance can be applied and factors to take into consideration 

when conducting a benefit-risk assessment.

I will also touch-on who performs a benefit-risk assessment. As Irene noted 

we have saved some time at the end for questions and during that time we will 

address any questions you have. A little bit of background, the draft guidance 

was issued in July of 2014. At that time we received 96 comments from nine 

different groups.

We received a handful of very similar comments and based on the feedback, 

the main revisions to the draft guidance fell into one of the three categories. 
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Firstly, we clarified that the guidance does not change the current 510(k) 

review process or SE standard. 

We also clarified that benefit-risk assessment does not imply submission of 

clinical data. This was a fairly common misunderstanding based on the 

feedback we received. Lastly, we clarified what is expected in a 510(k) 

benefit-risk assessment. 

As a reminder, a guidance document is not binding to FDA or the public. 

The draft guidance is intended for input and not implementation whereas the 

final guidance represents the agency’s current thinking on a specific topic. If 

a submitter chooses to use an alternative approach than the policy specified in 

a guidance, this is okay if it’s supported with appropriate scientific 

justification.

So, the final 510(k) benefit-risk guidance outlines the policy for evaluating 

substantial equivalence in a510(k) when the benefit-risk profile of a new 

device is different from that of a predicate device based on the performance 

data.

The guidance also specifies two situations when a benefit-risk assessment is 

recommended. The first situation is when there is an increase in risk along 

with an increase or equivalent benefit. The second scenario is when there is a 

decrease in benefit along with a decrease or equivalent risk when comparing a

new device to a predicate device.

There is also a section dedicated to performance data. As you know, the 

probable benefits and risk of a device are based on valid scientific evidence. 

Valid scientific evidence can include both non-clinical and clinical data. 

Section 4 of the guidance touches-on factors to be taken into consideration 
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when conducting a benefit-risk assessment. We will touch on these factors 

later in today’s training.

 The last section of the guidance includes example scenarios which walk 

through whether a benefit-risk assessment is recommended. If it is 

recommended, we address factors that were taking into consideration and how 

the assessment was used to inform the SE decision.

It is important to note that this guidance does not change the 510(k) premarket 

review standard nor does it create extra burden for submitters to provide 

additional performance data or information we would not typically request for 

in a 510(k).

The 510(k) benefit-risk guidance serves as an aid. It is intended to provide 

guidance specifically in situations when the benefit-risk profile of a new 

device is different from that of a predicate device. The guidance also provides 

additional clarification on factors FDA takes into consideration when 

conducting a benefit-risk assessment. 

Like all guidances, it is intended to improve predictability, consistency, and 

transparency.

So while a benefit-risk assessment is the basis for premarket review, it is 

important to understand that the benefit-risk framework for 510(k)s is 

fundamentally different from that of PMAs, De Novos and IDEs in the sense 

that for 510(k)s you’re comparing the benefit-risk profile of a new device to 

that of a predicate device in order to determine substantial equivalence.

Whereas for PMAs and De Novos, it is not a comparison. It is an independent 

assessment of a device’s benefit-risk profile. For IDEs it is also an 

independent assessment; however, we are willing to tolerate greater levels of 
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uncertainty prior to a clinical study that will help us garner more information 

on the benefit-risk profile of a new device.

Irrespective of the submission type, the probable benefits and risk of a device 

are based on valid scientific evidence. As I previously mentioned, valid 

scientific evidence can include both non-clinical and clinical data. I would 

also like to note that we do not typically see clinical data in 510(k) 

submissions. On average we see clinical data in less than 10% of 510(k) 

submissions we receive annually.

Of course FDA understands that there are situations when the benefit-risk profile of a new device 

is different from that of a predicate device; however, these differences do not 

automatically result in an NSE decision.

What FDA does, is we determine whether the differences impacts SE. As I 

previously mentioned, the guidance is intended to provide direction in 

situations when the benefit-risk profile of a new device is different from that 

of a predicate device. The guidance also specifies two situations when a 

benefit-risk assessment is recommended.

If we look at Quadrant 1 in the table on the right, a benefit-risk assessment is 

recommended in a situation where there is an increase in risk along with an 

increased or equivalent benefit. For the second scenario in Quadrant 3, 

benefit-risk assessment is also recommended when there is a decrease in 

benefit along with a decrease or equivalent risk.

If we look at the scenario in Quadrant 2 where there is an increase or 

equivalent benefit along with an increase or equivalent risk, this scenario is 

fairly clear cut and would likely result in an SE decision. If we look at the 

scenario in Quadrant 4 where there is an increased new risk along with an 
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increase in benefit, this is also fairly clear-cut and would likely result in an 

NSE decision.

So a benefit-risk assessment is recommended in a situation when the benefitrisk profile comparison falls under Quadrants 1 or 3 and if one is unsure 

whether the new device is substantially equivalent to a predicate device based 

on the differences in the benefit-risk profile.

The guidance includes a reference table that serves as a guide for when 

benefit-risk assessment is recommended. However, this table should not be 

used in isolation and should be used with the guiding principles outlined in the 

rest of the document. As I previously mentioned, there are a few situations 

when benefit-risk assessment is recommended.

For the scenario in Quadrant 1 where there is an increase in risk along with an 

increase or equivalent benefit, it is important to note that FDA will generally 

not deem a new device SE if there is an increase in risk that cannot be 

appropriately mitigated and if the increase in risk is not accompanied with an 

increase in benefit.

In the second scenario in Quadrant 3 where there is decrease in benefit and a 

decrease or equivalent risk, FDA will likely not find a new device 

substantially equivalent to the predicate if there is a decrease in benefit that is 

not accompanied with a decrease in risk and if the benefit-risk assessment 

confirms that the new device is not as safe and as effective as the predicate 

device.

So when can you conduct a benefit-risk assessment? Well, a benefit-risk 

assessment can be conducted after you have evaluated the performance data 

and determined that the benefit-risk profile comparison falls under Quadrants 
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1 or 3. For this guidance we leveraged the 510(k) decision-making flowchart 

and pointed to the step in the decision-making process when a benefit-risk 

assessment may be helpful.

We could not fit the whole flow chart on this slide without compromising 

readability, so in summary, a benefit-risk assessment is conducted after it is 

determined that the predicate device is legally marketed, the intended us of the 

new and predicate devices are the same and if there are differences in 

technological characteristics, the differences do not raise new questions of 

safety and effectiveness. Therefore, a benefit-risk assessment is conducted 

after decision 5A but before decision 5B.

When thinking about the effect of a device on patient’s health and/or clinical 

management, FDA considers several factors when evaluating the extent of 

probable benefit.

These factors include the type of benefit which is often predefined by 

endpoints, the magnitude of the benefit which is assessed based on these 

predefined endpoints and the probability that the patient will experience one 

or more benefits. FDA also considers whether there is variability and benefit 

within sub-populations in a group.

We also consider the duration of effect. This also helps us to determine 

whether use of the device or intervention is worth it. Likewise, FDA 

considers several factors when evaluating the extent of probable risk including 

the type, severity, rate, and probability of harmful events. 

In other words what is the risk, how bad is it, how frequently does it occur,

and what are the chances that it will occur? FDA also considers the 

probability that the patient will experience one or more harmful events and if 
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the device is a diagnostic device, we consider the risk from false positive or 

false negative results. In other words, what are the chances that a patient will 

accidentally receive or not receive a treatment that they need? 

This slide shows the additional factors that FDA takes into consideration 

when conducting a benefit-risk assessment. Section 4 of the guidance touches

on each of these factors in detail.

For this training, I will touch-on each factor very briefly. Uncertainty in a 

benefit or risk can be due to the quality or lack of quality of valid scientific 

evidence. A number of factors can affect the degree of uncertainty including 

things such as poor bench testing, small sample size, inadequate data analysis 

or poor study design.

FDA also considers the disease condition. In other words how does the 

disease manifest within a patient, what are the symptoms and how is the 

disease currently treated?

We also value patient perspective because we understand that the way a 

patient perceives a benefit or risk might be different to that of a scientist or 

clinician. Additionally, there are patients who are willing to tolerate more risk 

in order to gain the benefits of a device. 

FDA also considers the benefit for the healthcare professional, patient or 

caregiver because we recognize that there are tools that could positively affect 

or improve patient management; and in a situation where there’s an increase 

in risk when comparing a new device to that of a predicate device, risk 

mitigation strategies could help to minimize the probability or severity of a 

harmful event.
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Post-market data is also important because it could help to provide 

understanding of the benefits and risks of similar devices and this information 

can be leveraged when conducting a benefit-risk assessment of a new device. 

So who performs a benefit-risk assessment?

Well, if a benefit-risk profile comparison fits under Quadrants 1 or 3, the 

submitter can include a benefit-risk assessment in a 510(k); however, it is not 

required. If the lead reviewer determines that the benefit-risk profile 

comparison fits under Quadrants 1 or 3, the lead reviewer performs the 

benefit-risk assessment.

And if there isn’t sufficient information in the submission to complete the 

assessment, the lead reviewer can request for additional information from the 

submitter to help complete the assessment. 

As I previously mentioned, if there isn’t sufficient information in the 

submission, FDA can request for additional information to help complete a 

benefit-risk assessment.

This is an example deficiency FDA could issue if additional information is 

needed. The deficiency request for a summary of the benefits and risks, any 

additional factors such as risk mitigation or post-marking data that was taken 

into consideration.

In Part D we request for a conclusion on whether the benefits outweigh the 

risks. I also want to note that if a benefit-risk assessment was used to support 

substantial equivalence, a summary of the benefit-risk assessment should be 

included in the 510(k) summary.

In the next few slides, we will go through two example scenarios where a 

benefit-risk assessment is recommended. In this first scenario we have the 
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manufacturer of a condom, fabricated from synthetic material and the 

submitter is claiming SE to a natural rubber latex condom.

The only technological difference between both devices is the material; 

however, there was concern that the new material may not perform as well as 

the natural rubber latex and could result in breakage or slippage during sexual 

intercourse.

To assess these risks, the submitter performed a clinical study and assessed 

breakage and slippage as endpoints. The primary endpoints were met; 

however, the slippage rate for the synthetic condom was slightly higher than 

that of natural rubber latex condoms.

When we conduct a benefit-risk assessment we assess the overall benefits and 

overall risks based on the performance data. The benefit in this situation is 

that the new device provides another option for contraception and 

prophylactic particularly for people with an allergy to natural rubber latex.

The risk is that there is a slight increase in the slippage in comparison to that 

of natural rubber latex condoms which could result in increase of undesired 

pregnancies or STIs. When we consider additional factors, the submitter 

included a warning label stating that the device should only be used if the user 

has an allergy to natural rubber latex.

For the 510(k) analysis we consider the benefit-risk assessment. We 

acknowledge the benefit, in this case the device provided a form of 

contraception for people with an allergy to natural rubber latex.

However, the clinical study showed an increase in slippage rate in comparison 

to that of the predicate device; however, this risk was partially mitigated with 
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inclusion of warnings in the labeling so because the increase in risk was 

partially mitigated and because the increase in risk was also accompanied with 

an increase in benefit, the new device would likely be found substantially 

equivalent.

For this second example we have a laser therapy device for treatment of 

toenail fungus. This new device uses a different wavelength than the 

predicate device. The wavelength in the new device produces different 

photobiological effects in comparison to the predicate device.

It also has a constant energy delivery sequence whereas the new device has a 

pulsing sequence. A little bit of background for treatment of toenail fungus. 

There are two mechanisms of action. One is photobiological whereby the 

laser interacts with the chromophores within a fungal cell resulting cell death.

The second mechanism is a thermal effect on fungal cells where the cells are 

exposed to temperatures that result in tissue coagulation or vaporization. Due 

to the technological differences, the submitter conducted a clinical study 

comparing the new device to the predicate device.

The device would have equivalent benefit if it had a comparable responder 

rate to that of the predicate device so a responder is a subject whose toenail is 

effectively treated according to predefined success criteria.

The results of the clinical study showed that the clinical rate was lower in the 

group treated with the new device; however, due to the low power level the 

new device poses a lower risk in comparison to that of the predicate device.

So as we assess both the benefits and risks in comparison to the predicate 

device, for the benefits the new device offers and alternative treatment option; 
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however, the clinical study showed a lower responder rate. For the risk the 

lower power level for the new device offers minimal side effects when 

comparing the new device to the predicate device.

We took two additional factors into consideration: uncertainty and risk 

mitigation. There were significant data inconsistencies based on the data 

provided which resulted in a high degree of uncertainty. For risk mitigation 

we acknowledged that the laser safety protective glasses can be used to 

prevent accidental eye damage.

For the SE analysis we acknowledged that the clinical data showed that the 

new device had a lower responder rate. Although the new device imparts less 

risk due to the lower power level, the benefit was considerably smaller. 

Considering the high degree of uncertainty and small benefits observed, the 

new device would likely be found NSE based on lack of adequate 

performance data.

I do want to note that while the examples included in this training require 

clinical data, there are additional examples in the guidance where a benefitrisk assessment was conducted without the need for clinical data.

Considering the objectives of this training, there are three take-home 

messages. Firstly, FDA has released the final 510(k) benefit-risk guidance 

that serves as an aid when evaluating the benefit-risk profile of a new device 

especially in situations where there are differences in the benefit-risk profile 

of a new device in comparison to a predicate device.

Secondly, the guidance also specifies two scenarios where a benefit-risk 

assessment is recommended. Lastly, FDA understands that the benefit-risk 

profile of a new device does not have to be identical to that of a predicate 
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device and in situations where there are differences, FDA assesses how the 

differences impact substantial equivalence.

The benefit-risk assessment is not the final decision, but it’s used to inform 

the final decision. This slide includes a link to the final 510(k) benefit-risk 

guidance. It also includes a link to existing guidance documents referenced in 

the subject guidance. I won’t go through the list but the links on the slide are 

applicable.

Thank you all for calling-in to today’s Webinar. We understand that this is a 

new policy so if you have any questions pertaining to the policy discussed 

today, please feel free to e-mail 510(k) staff. We check our mailbox between 

8:00 to 4:00 pm during the weekdays and if you have any general questions,

please feel free to e-mail DICE.

Thank you all for attending once again and we are ready to address any 

questions you have at this time.

Coordinator: Thank you and at this time to ask your question, please press star then 1. 

Please unmute your phone and record your name clearly at the prompt. To 

withdraw your request, please press star 2. Once again please press star 1 at 

this time to ask your question. One moment, please, for the first question. 

Ifeanyi Uwemedimo: So while the questions are being queued, one common question we have 

received is does this policy change the NSE decision process? The answer is 

no. Benefit-risk assessment is used to inform the final decision. It is not the 

final decision nor does it change the final decision. Another question is what 

if you’re unsure whether you need to include a benefit-risk assessment? 
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As we’ve previously mentioned a submitter can choose to include a benefitrisk assessment but it’s not required and if you are unsure, we recommend 

referencing Table 1 in the guidance to determine whether the profile

comparison fits into one of the quadrants and if you’re still unsure, again you 

can always contact 510(k) staff. 

Irene Aihie: Operator, we can take our first question.

Coordinator: Thank you. The first question is from (Ann Leonard). Your line is open.

(Ann Leonard): Yes, hi. I just wanted to ask then whether one would expect to see going 

forward that there would always be a risk-benefit sort of evaluation or 

conclusion in all of the 510(k) summaries, either whether they’re produced by 

the sponsor or whether it’s the work of the reviewer? Will either 510(k) now 

have a risk-benefit evaluation either summary or conclusion?

Ifeanyi Uwemedimo: So we’re not expecting to see a benefit-risk assessment for all 510(k)s. 

Again the guidance does outline the two scenarios where a benefit-risk 

assessment is recommended and we anticipate that the chances of actually 

including a benefit-risk assessment will be fairly slim and again as we 

mentioned during the training, the submitter is not really required to include a 

benefit-risk assessment; however, you do have the option.

But in a situation where the lead reviewer determines that the benefit-risk 

profile comparison falls into either Quadrants 1 or 3, the lead reviewer is 

expected to complete a benefit-risk assessment.

(Ann Leonard): Okay, thank you.
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Coordinator: The next question is from (Almda) and please state your company name when 

presenting your question, your line is open.

(Almda): Hi, hello, I’m calling from (grateful diagnostic solutions). My question is 

about the situation when the new device and the predicate device have the 

same technological characteristics as a predicate so you this case assume we 

don’t need do this benefit and risk analysis?

And related question is like the (venme) if they have the same technological 

characteristics there is no further like benefit or risk ratio, use this situation?

Ifeanyi Uwemedimo: So I’ll attempt to address your question and you can let me know whether 

I addressed it appropriately or not so a benefit-risk assessment is conducted 

after you’ve provided your performance data and you’ve determined that your 

benefit-risk profile comparison falls into one of the two quadrants that we 

previously mentioned. 

In that case that’s when we will expect to see a benefit-risk assessment; 

however, if it has the same technological characteristics and there isn’t any 

substantial difference in the benefit-risk profile comparison, then we would 

not expect to see a benefit-risk assessment. Does that address your question?

(Almda): Yes and okay, maybe you can show me the slide. Yes, I was a little bit 

overlooked that. 

Ifeanyi Uwemedimo: So before you even consider conducting a benefit-risk assessment, you 

already identify whether there is differences in technological characteristics or 

not and if there are differences, you have to first confirm that they do not raise 

any questions of safety and effectiveness. Again the benefit-risk assessment is 

only conducted after you’ve evaluated the performance data. 
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(Almda): Yes, my follow-up, if I remember that I see regulating correctly, when you 

have the same intended use and the same technological characteristics, you 

already have the substantial equivalent. Only when the technological 

characteristics are different you need to assess why they have I would say any 

effect on the safety and effectiveness.

So based on your FDA regulation, if they have the same technological 

characteristics or they have what substantial equivalence so in this case I 

shouldn’t, you know, do the benefit and risk evaluation because it’s not 

necessary.

Ifeanyi Uwemedimo: Correct.

(Almda): Okay, so does that mean that applied to the difference in the technological 

characteristics situation, you mean?

Ifeanyi Uwemedimo: I’m sorry, can you repeat that question?

(Almda): Okay, so I kind of assume this guidance mainly applies to when there is a 

difference in technological characteristics.

Ifeanyi Uwemedimo: Yes.

(Almda): Yes, okay. Okay, thank you.

Ifeanyi Uwemedimo: Thank you.

(Almda): No but when they have the same characteristics ...
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Coordinator: The next question is from Adrienne Lenz. Your line is open and please state 

your company.

Adrienne Lenz: Hello, this is Adrienne Lenz with Hyman, Phelps & McNamara. My question 

is how will you handle situations where there’s (unintelligible) information 

available regarding a predicate device, for example that the predicate was 

cleared under a previous guidance document where FDA may not have 

considered risks that they would be looking at today for a new device?

Ifeanyi Uwemedimo: That is a good question Adrienne. Can you give us a second to discuss it 

briefly?

Adrienne Lenz: Sure. 

Ifeanyi Uwemedimo: So I just want to note that with use of the guidance our standard hasn’t 

changed and we’ll still consider the factors that we’ve outlined in the 

guidance. 

((Crosstalk))

Adrienne Lenz: Yes, I just wasn’t sure if there was more, thank you.

Ifeanyi Uwemedimo: And of course we’ll handle each situation on a case-by-case basis but I 

think the important point that we are trying to make it that the standard has not 

- the standards for 510(k) - has not changed.

Irene Aihie: Okay, we’ll take our next question.

Coordinator: Next question from Mark DuVal and please state your company.
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Mark DuVal: Yes, Mark DuVal, DuVal and Associates here in Minneapolis. Just a 

question. We filed a docket submission on risk-benefit in 510(k)s two-three 

years ago, I can’t remember now and challenging the agency’s thinking on 

this that the Agency seemed to be, in our viewpoint, sort of legislating new 

requirements into the 510(k) program that really don’t have its foundation in 

the statutes or the regulations.

So you shouldn’t as a 510(k) device inherit the underlying regulatory 

presumptions that the device has already established safety and effectiveness 

and we shouldn’t have to revisit that or a clinical utility and yet that sort of 

seems to be what we’re doing here in a risk-benefit analysis. 

I think I understand where the agency’s trying to go with this but I’m not sure 

I think by doing this we’re sort of emasculating the 510(k) program and if we 

want to change it, that’s fine but we need to go to Congress to do it and I’m 

just wondering how you got there and how you believe that this is not 

tantamount to a legislative or regulatory change without either a statute or 

promulgating a new regulation.

Ifeanyi Uwemedimo: So we’re not changing the 510(k) statute or regulation and I think the way 

we really want you to receive or understand this guidance is that it really 

serves as a structured tool when you’re having a hard time reaching a final 

decision based on the performance data.

Mark DuVal: But can’t we always punt to the performance data anyway and if it’s really

that different of a device, the outlet then would be I guess the De Novo

program but the quantum and the quality of the data is one thing to request but 

to sort of fundamentally structure or build into the 510(k) program risk-benefit 

is just it seems to me this sort of mindless escalation of new requirements that 

really don’t have any lineage in the statute or the regulation.
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It’s just kind of maybe a convenience for the agency put its mind around how 

it looks at things but now there’s a layer added-on for industry to have to now 

do risk-benefit analyses whenever it’s so deemed by the agency. Now they 

might be few and far between in the beginning but it might be commonplace 

five years from now.

((Crosstalk))

Woman: Hi, this is Angie Krueger. I think I would (enter) that by saying that the 

statutory and regulatory basis for the guidance is outlined in the guidance and 

we believe that the policy is squarely within the regulatory authority that we 

have so we’re not changing the standard as Ifeanyi has noted and we also 

believe that it’s built into the decision-making process in the regulatory 

approach that we take.

So I’d refer you to the regulatory section and background in the guidance to 

outline our thinking on that particular issue.

Mark DuVal: Good, we’ll do that, thank you.

Coordinator: Next question is from Abdel Halim. Your line is open and please state your 

company.

Abdel Halim: Sure, Biomarkers and Diagnostics Consulting so my question is related to 

technological characteristics. Do you consider the analytics performance 

specifications or the mechanism of action (unintelligible) IVD or both? 

For example, can next-generation sequencing compared to PCR or (fish 

versus catch) or whatever (light have) by fluorescents or by color-emitting, 
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can all of this be considered as technologically similar or the mechanism of

action or platform need to be similar and if they are not similar, can be (man) 

clinical data enough to mitigate or to show the equivalent?

Ifeanyi Uwemedimo: Thank you for your question so your question is very device-specific and 

we would recommend contacting DICE to find a representative from OIR to 

help address your question adequately.

Abdel Halim: Thank you.

Coordinator: And once again to ask a question at this time, please press star then 1. One 

moment, please. 

Irene Aihie: Operator are there any questions?

Coordinator: Thank you, we are showing no further questions. We’ll turn it back over to 

Irene Aihie for closing remarks.

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

thoughtful questions. The presentation and transcript will be made available 

on the CDRH line Webpage at www.fda.gov/training/cdrhlearn by Friday, 

November 9th. If you have additional questions about today’s presentation, 

please use the contact information provided in the slide presentation. 

As always we appreciate your feedback. Following the conclusion of today’s 

Webinar, please complete a short 13-question survey about your FDA CDRH 

Webinar series. This survey can be found at www.fda.gov/cdrhwebinar 

immediately following the conclusion of today’s live Webinar. Again, thank 

you for participating. This concludes today’s Webinar.
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Coordinator: Thank you. That does conclude our conference. We appreciate you 

attending. You may disconnect at this time.

END