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Webinar: Final Guidance on Factors to Consider Regarding Benefit-Risk in Medical 

Device Product Availability, Compliance, and Enforcement Decisions

Moderator: Irene Aihie

February 9, 2017

1:00 pm ET

Coordinator: Good afternoon. And thank you for standing by. For the duration of today's 

conference, all participant's lines are on a listen only mode until the question 

and answer session. At that time, if you have a question, press star 1. Today's 

call is being recorded. If you have any objections, you may disconnect at this 

time. It is my pleasure to introduce Ms. Irene Aihie. Thank you, ma'am, you 

may begin.

Irene Aihie: Hello. And welcome to today's FDA webinar. I am Irene Aihie at CDRH's 

Office of Communications and Education. On December 27, 2016, the FDA 

issued the final guidance on factors to consider regarding benefit risk and 

medical device product availability, compliance and enforcement decisions. 

This guidance document is intended to clarify the FDA's approach to 

weighing benefits and risks for medical device product availability, 

compliance and enforcement decisions.

The purpose of today's webinar is to share information and answer questions 

about the final guidance document. Today's presenter is Ann Ferriter, Director 

of the Division of Analysis and Program Operations in the Office of 

Compliance here in the Center for Devices and Radiological Health. 

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

to topics in the final guidance only. Additionally, there are other Center 

subject matter experts available to assist with the Q&A portion of our 

webinar. Now, I give you Ann.
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Ann Ferriter: Thank you, Irene, and good afternoon, everyone. Thank you for joining this 

webinar discussing the final guidance factors to consider regarding benefit 

risk and medical device product availability, compliance and enforcement 

decisions. As Irene said, I am the Director of Analysis and Program 

Operations within CDRH's Office of Compliance. And I'm very pleased to 

have the opportunity to speak with you today.

Over the next half hour, I'll be discussing what I believe to be a very 

significant guidance document to focus the actions of both FDA and industry 

on decision making in a manner that is in the best interest of the patient and 

overall public health.

The objectives of today's webinar are to clarify the scope and describe the key 

elements of the new draft guidance, to outline FDA's motivation behind 

drafting the guidance, to share the factors the Agency considers when 

evaluating both risk and benefits in making decisions and to discuss additional 

factors that should be considered when making these decisions in the best 

interests of patients, and finally to provide examples of how the agency and 

industry may apply the guidance.

Before we start on the guidance itself, I'd like to share the why behind why we 

drafted the guidance. The first and most important reason is to focus on the 

patients. We, and this is OC (Office of Compliance), OIR (Office of In Vitro 

Diagnostics and Radiological Health), and ORA (Office of Regulatory 

Affairs), really strive to make decisions that put the patient first. We take the 

FDA mission to promote and protect public health very seriously.

Across OC, OIR and ORA, we've always assessed benefit and risk. We wrote 

this guidance together drawing on the best thinking across the medical device 
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compliance program so that we can consistently and systematically apply the 

same factors.

And continuing with why we drafted the guidance, we recognized the FDA 

was not always aligned with industry and we lacked transparency in our 

decision making. Through collaboration over the past three years, the industry 

comments on the guidance, and FDA industry pilots in 2016, we learned more 

about how to have these constructive benefit risk discussions. The guidance 

helps to facilitate our conversations and leads towards a focus on quality, 

patient benefit and consideration of patient preferences.

The guidance states FDA intends to use pilots and other evaluation techniques 

to help determine how to apply the benefit risk framework. There's a lot of 

new thinking that we can do. We're already shifting and beginning to apply 

the benefit risk factors across our work products.

And finally, ODE (Office of Device Evaluation) has drafted three benefit risk 

guidance documents, the new emerging signals guidance leverages, this 

thinking across CDRH we have listed our gaze to the patient. This document 

brings together the compliance staff activities into alignment as well.

This page depicts the front cover of the guidance document which issued in 

final on December 17, 2016. The draft guidance issued June 16, 2016, and 

there was a 90-day comment period. In September, we received comments 

and based on the comments, worked to revise the draft.

The key points, if you don't take anything else away from this discussion, the 

key points, as you read this guidance, first the guidance is designed to 

complement thinking and rationale that exists in the pre-market benefit risk 
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documents. We used the PMA (Premarket Approval) benefit risk documents 

as a guide during the original drafting.

Second, the guidance is intended to apply broadly to regulatory and 

compliance thinking and to inform decisions that may impact product 

availability, potential compliance strategies as well as considering various 

enforcement options and actions available to the agency.

The goal is to secure the level of compliance necessary to ensure that products 

on the U.S. market are both safe and effective. And the third purpose of in

forming these compliance and enforcement decisions is really to maximize 

patient benefit.

The webinar today will follow the guidance table of contents. There are six 

sections in the guidance as well as four appendices. I will review each section 

in detail. A link to the posted final guidance is provided at the bottom of this 

page.

In the introduction, the guidance document emphasizes improving clarity for 

FDA staff and industry as well as maximizing medical device quality and 

patient safety. We believe that by explaining and gaining a better shared 

understanding around benefit risk decision-making and compliance, both the 

agency and industry will be able to better prioritize the use of resources to 

focus actions that maximize patient benefit, reduce patient risk and improve 

overall medical device quality.

This benefit risk guidance document encourages not only FDA but also 

industry to apply the same lens and strategy to addressing potential 

compliance issues and to take actions that make the most sense for patients.
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We provide a little bit of information about the logistics of how FDA will 

implement the guidance. We've already started by running six pilots in 2016 

and then ranging across OC, OIR and ORA and even ODE in many case study 

discussions. We feel it's especially important to learn from our pre-market 

folks and therefore have attended their pre-market benefit risk rounds and 

pulled their pre-market benefit risk assessments. As the Center continues with 

our strategic priorities, we are learning more about how to gather and use 

patient information as well as alternative sources of data or real world 

evidence.

The scope of the guidance is both broad in the range of decisions and narrow 

in the range of products. Here are a few examples to illustrate the range of 

decisions where benefit risk factor considerations may be appropriate. 

Situations where the withdrawal of a violative medical device or recall of a 

product due to a manufacturer's non-compliance that could result in 

significant device shortages for patients and their physicians is one of the key 

places where this guidance would be applicable.

Not every regulatory non-compliance is the same or has the same potential 

impact to product or patient. As a result, it is important to select the most 

appropriate regulatory engagement mechanism or action for the situation at 

hand. What actions, if any, FDA may take when continued access to a nonconforming or device manufactured by a firm with a regulatory compliance 

issue, those actions must be considered during a shortage situation.

When a recall is indicated, there are a variety of ways in which this recall may 

be handled. Benefit risk factors may be important devising a recall strategy 

that is in the best interest of patients.
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When should a firm's recall strategy include a correction instead of a removal? 

Benefit risk factors may also be considered when they are negative 

inspectional observations during an inspection such as the PMA approval 

inspection. And then a company may petition for a variance from certain QS 

(Quality Systems) regulations.

When is it in the best interest of public health to grant this variance? While the 

range of decisions you could apply this guidance is broad, the area of 

application is narrow. This document applies to medical devices both 

diagnostic and therapeutic, but not to devices regulated by CBER (Center for 

Biologics Evaluation and Research) or combinations products where CDRH 

is not the lead. The guidance document does not apply to EPRC products or 

other products regulated by FDA such as drugs and biologics.

Section three is really focused on the patient. FDA has the authority to limit 

the availability of violative medical devices and pursue compliance and 

enforcement actions related to those violative medical devices. But FDA 

recognizes that to achieve the Agency's goal of protecting and promoting 

public health, decisions regarding these actions should be made while 

focusing on the impact of patients. Failure to consider the short term and long 

term impact of non-compliance on the benefit risk profile of the device and 

the benefit risk trade-off of FDA's decision options could result in regulatory 

actions with unintended adverse effects. For example, the shortage of medical 

necessary devices.

Section four includes a description of factors to consider. The first part is the 

factors to consider for the assessment of medical device benefits. The type of 

benefit includes, but isn't limited to, the medical device's impact on patient 

health and clinical management. So it's the effect of the device on patient
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treatment plans and quality of life, impact on survival and how much the 

medical device can aid in improving patient function.

Magnitude of benefits is the degree to which patients experience the treatment 

benefit or the effectiveness of the medical device. The change in patient's 

conditions or the change in the necessary clinical management may allow 

FDA to determine the magnitude of the benefit. Then the likelihood of 

patients experiencing one or more benefits is also key.

The FDA may consider whether there's a subpopulation included in the 

indication for use that are more likely to retain expected benefits than the 

overall population. If subpopulations can be identified, the likelihood of those 

patients experiencing benefit from the device may increase.

The duration effect is how long the benefit can be expected to last for the 

patient. Knowledge of the duration of treatment may change as the medical 

device is used.

Another factor is the patient preference on benefit. This is the value that 

patients place on the use of the medical device. Faced with a severe or chronic 

disease, a patient may highly value that benefit provided by the medical 

device in light of the specific condition that the patient has.

For example, patients dying of congestive heart failure may highly value a 

medical device that extends their lives for a few months. Patients with less 

severe chronic diseases may or may not place the same value on a device with 

a short-term benefit.
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Benefit factors for health care professionals or care givers include the benefit 

that they experience by improving the way they care for patients, whether this 

directly improves patient outcomes or includes clinical practice.

The FDA recognizes that certain devices, such as surgical tools that allow 

different techniques or devices that positively affect ongoing patient 

management may improve the benefit profile.

And the last factor we consider is medical necessity. If a medical device 

provides benefit or addresses unmet needs, this should be a major factor on 

whether a device would be available for use with patients.

The second section under the description of factors to consider are the factors 

for the assessment of medical device risks. The severity of harm has always 

been the first thing we consider. This, like with MDRs (Medical Device 

Reports), is categorized into three levels. Related deaths or serious injuries, 

non-serious adverse events which include temporary or medically reversible 

events, and events without reported harm.

Then we consider the likelihood of risk. And we encourage manufacturers 

wishing to provide data and calculations to talk with the FDA regarding that 

information.

We look at whether a non-conforming product has been distributed or not and 

the duration of the exposure of the population to that non-conforming product. 

For diagnostics, false positive and false negative results are especially 

important. As with benefits, we look at the patient's perspective.

So the patient's tolerance for risk is the concern the patients have regarding the 

harm or potential harm caused by the device. Patient tolerance of risk may 

take into account both the patient's willingness and unwillingness to use a
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non-conforming medical device, to use a device manufactured by a noncompliance manufacturer or to tolerate harm, both probable and actual. Risk 

factors for health care professionals or caregivers may also be considered. 

And then the third section under factors to consider is the additional benefit 

risk factors. These were factors that didn't neatly fall into either benefit or risk, 

but are critical to FDA's decision-making process. Uncertainty, there's never 

100 percent certainty regarding the safety, effectiveness or quality of a device. 

However, the degree of certainty of the benefits and risks is a factor FDA 

considers when making decisions.

Mitigations. The actions taken by the manufacturer, by the FDA or other 

stakeholders to recover benefit limit risk from non-conforming product to 

address underlying quality system problems or to limit harm. There's different 

ways of mitigating risk. It could be clinical practice. It could be addressing 

use errors, looking at the use environment. FDA considers all of these factors 

and whether the mitigation is proposed or in place in our decision making.

Relating to mitigation, we're concerned with whether the problem for nonconformity can be identified by the manufacturer or by the user.

The failure mode is considered whether it's a systematic failure, or there's a 

non-conformance that's related to manufacturing, design, use conditions or 

environment.

We look at the scope of the device issue, whether this is a problem limited to a 

single lot or batch of devices or whether this problem is inherent to similar 

devices of this type.
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We look at the impact on the patient both if the product is available and if it is 

not. We talk to patients and understand the preference for availability. And 

then in a more industry-focused way, we look at the nature of the violations 

and the type of non-conformance of the product.

And, finally, we consider the firm's compliance history. A manufacturer with 

a good regulatory history and who has demonstrated initiative in identifying 

any corrective issues may get a more collaborative opportunity from the FDA.

Since this is an overarching guidance that addresses many processes in 

compliance and enforcement, the section on how FDA considers benefit and 

risk is written at a very high level. When FDA looks at benefit risk, it's a fairly 

straightforward process.

The first thing we do is identify the issue and decide whether the issue 

requires a benefit risk analysis. We then gather whatever benefit information 

is available to us. We encourage manufacturers that wish to provide benefit 

risk documentation to do so through the designated FDA point of contact.

For example, for a recall, you would reach out to the District Recall 

Coordinator. If you'd like to understand the types of benefit information that 

would be helpful to share with the District Recall Coordinator, please consider 

the worksheet in Appendix D.

So after we gather the benefit information, we gather whatever risk 

information is available to us, the process of systematically gathering risk 

information is more familiar to FDA and industry. For years, we've been using 

the health hazard evaluation form. And then FDA considers this list of other 

relevant factors that I had just mentioned to you.
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Section 5 of the guidance describes when benefit risk considerations may be 

useful in making a product availability decision. These include situations 

where the firm's recall strategy might appropriately include a correction 

instead of a removal, includes when deciding what actions, if any, FDA may 

take when continued access to a non-conforming device or device 

manufactured by a firm with regulatory compliance issues might be needed or 

if a market withdrawal would result in product shortage for patients.

Section 5 also notes when benefit risk considerations may be useful in making 

a compliance and enforcement decision. For example, when it is in the best 

interest of public health to grant a variance from certain quality system 

regulatory requirements such as maybe process validation issues if these have 

been identified during a PMA pre-approval inspection.

Once the benefit risk assessment has been completed, FDA uses this 

information in several ways. We use this in determining the adequacy of a 

manufacturer's proposed correction strategy or mitigation and would use this 

information in determining whether an observed violation requires a warning 

or an entitled letter or an alternative less formal approach.

For product availability decisions, we'd use benefit risk factors to consider 

whether a patient should have continued access to the device or whether we 

should take steps to limit product availability.

For compliance and enforcement decisions, we'll use benefit risk to consider 

when we might work with a manufacturer to address the underlying issues or 

when it was time to take a more formal compliance for enforcement action.

Section 6 of the guidance provides specific examples of how benefit risk 

assessments may be applied, including benefit risk factors discussed today as 
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well as the more general factors like uncertainty and potential mitigations. 

Each example addresses a key situation, such as a circumstance in which a 

recall may generate a shortage and then walks the reader through logic and 

decision making required to do the benefit risk assessment.

The specific examples include recall and shortage generation, a variance 

petition and continued access to a non-conforming product. After reading the 

comments on the draft guidance, we added IVD (In Vitro Diagnostic) and a 

rad(radiological) health example. The examples related to compliance 

enforcement decisions include an evaluation of whether to send a warning 

letter or take an alternative approach and an evaluation of potential actions 

following an inspection of a manufacturer with observed quality system 

deficiencies.

Appendix A of the guidance describes the intersection with ISO (International 

Organization for Standardization) 14971. ISO 14971 is an FDA recognized 

standard and assuring conformity with this standard may help device 

manufacturers meet requirements specified in FDA regulations. The 

documentation of risk management decisions by manufacturers may help 

streamline these decisions for both FDA and manufacturers producing 

outcomes for patients that deliver the most benefit for the least amount of risk 

and providing a reasonable assurance of safety and effectiveness.

And finally, in Appendices B, C and D the guidance provides a series of 

worksheets for both FDA and the manufacturers to facilitate good benefit risk 

decision making.

Appendix B contains a worksheet to help us think through benefit in a 

systematic way. Using the seven factors that I described that were type of 

benefit, magnitude of benefit, likelihood of patients experiencing one or more 
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of benefits, duration of effect, patient perspective on benefit, benefit factors 

for health care professionals and medical necessity. The worksheet provides a 

series of questions that strengthen our understanding of benefits. For example, 

the questions on this slide relate to the magnitude of benefit and the patient 

perspective on benefit.

One of the key elements of benefit is medical necessity. And we have 

questions in Appendix B that help us consistently and systematically think 

through what is meant by medical necessity.

Appendix C is used for risk assessment, including serious events as well as an 

assessment of temporary or non-serious events. As with Appendix B, 

Appendix C is organized around the seven factors related to risk, like severity 

of harm and likelihood of risk as shown on this slide.

And the last Appendix B slide has questions related to non-conforming 

devices and patient tolerance of risks. Appendix D contains those other 

factors. Nine factors that don't fit neatly as benefit or risk but are needed in

making product availability, compliance and enforcement decisions. These 

factors included uncertainty, mitigation, detectability, failure mode, scope of 

the device issue, patient impact, et cetera.

The questions on this slide focus on uncertainty and impact to the patient.

And on the final slide this shows some of those other factors and questions 

related to the nature of violations for non-conforming product as well as firm 

compliance history.
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So this concludes the presentation part of today's webinar. I hope the 

description of the guidance document has been helpful. I'm going to turn the 

mic over now and we'll open it up for questions.

Coordinator: Thank you. If you would like to ask a question, please unmute your phone, 

press star followed by the number one. And when prompted, record your 

name clearly so I may introduce you. To withdraw your question, press star 

two. Again, to ask a question, star one.

We have one question from (Elise Mensias). Go ahead. Your line is open.

Irene Aihie: Operator, do we have any other questions?

Coordinator: I show no additional questions at this time. As a reminder, if you would like to 

ask a question, press star followed by the number one. One moment please.

Our next question comes from Mark McCarty. Go ahead, your line is open.

Mark McCarty: Hi. Thank you very much for taking the question. Ann, you mentioned 

something about six pilot projects that you have related to this guidance. I was 

wondering if you could offer a little bit more detail on those.

Ann Ferriter: Sure. Because this is a broad overarching guidance, we ran a series of pilots in 

2016 to understand how this guidance document related to processes within 

the Office of Compliance, OIR and ORA. So we ran a pilot looking at 

allegations of failure to submit appropriate pre-market submissions. We 

looked at allegations of issues in clinical trials. We looked at EIR reviews, 

recalls. And we did a series of case studies.

Mark McCarty: Can you talk a little bit about some of things you learned from the pilots?
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Ann Ferriter: Sure. So we learned that we're a lot more skilled in understanding risk than we 

are in understanding benefit. And that we have ready access to risk 

information but working with a company to understand benefit and understand 

the landscapes that this device was operating in was a little bit more 

challenging for both FDA and industry. And so we really had to take a step 

back and develop some basic questions, basic forms so that we would 

consistently gather similar information on benefit.

Mark McCarty: All right. Super. Thank you very much.

Ann Ferriter: Thank you.

Coordinator: Our next question comes from (Linda Chapman). Go ahead, your line is open.

(Linda Chapman):Thank you for the walkthrough on the guidance document. It was very 

helpful. My question is around whether it would be beneficial for private 

industry to follow some of the rationale in the guidance document as they do 

their internal risk benefit analysis.

Ann Ferriter: We believe it would be very helpful. This guidance document was written to 

better align FDA and industry. And so as industry adopts looking at these 

same factors in considering benefit risk in the same way, we believe that we'll 

have more constructive conversations.

(Linda Chapman):Thank you. So if a company did that and those risk management analyses 

were in their files when FDA inspected, would that have positive effect maybe 

on the inspection itself?
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Ann Ferriter: Since you included the word maybe, absolutely. So, of course, this would be a 

case-by-case basis. Every investigator would be looking for particular things. 

And there could be a case where a firm has documented benefit risk 

assessment as per the guidance and not gotten it right. So we're going to leave 

that possibility open.

But by using the guidance, what you do is you start on the same page as that 

investigator.

(Linda Chapman): Okay, great. Thank you very much.

Ann Ferriter: Thank you, Linda.

Coordinator: Our next question comes from Karen Hughes. Go ahead, your line is open.

Karen Hughes: Hi and thank you. Couple questions. So one for certain submissions, for 

example, for a de novo, a risk benefit determination using the worksheets in 

the other risk benefit guidance which look like they overlap quite well with 

what's in this guidance, are generated by FDA and the applicant.

And so I was wondering, there is, of course, a summary of that, for example, 

in a de novo summary on the FDA Web site. How might that be used by FDA 

when it exists? And, I think, you also mentioned you, in the case of a recall, 

you might reach out to the district coordinator. How is that communication 

that that information exists or is that only viewed as value at the time of the 

application for the de novo?

Ann Ferriter: Absolutely. We very much value the benefit risk assessments that have been 

conducted by the pre-market staff. And we have direct access to them. So on 

the FDA side, we'll be using them. I would recommend companies also, if 
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they're interested in sharing the pre-market analysis with the recall 

coordinator, that would be a good step. The recall coordinator will also have 

access to that. But perhaps they missed it. So it's never a bad idea to share it 

again or emphasize the importance of the analysis.

Karen Hughes: Great. Thank you. And then just one other question, I know the guidance is 

now released and no longer in draft. But I didn't know if there would be an 

opportunity at any other time, maybe even on device advice.

I'm a diagnostics manufacturer. And while I found - I'm grateful that you 

included a test as an example in the guidance, the pregnancy test, it's kind of 

an easy example because the patient is directly involved. But it doesn't really 

cover all of those hospital tests where it's a little harder sometimes for maybe 

the patient to be able to say what their direct benefit is because it's "to them 

just another lab test."

So just some feedback that if there is an opportunity for something, you know, 

anything like a Troponin versus maybe something that would be considered 

lowered risk, which I can't think of off the top of my head, but something like 

that might be of value as well.

Ann Ferriter: Thank you for that feedback, Karen.

Coordinator: Our next question comes from (Padmini Sahou). Go ahead, your line is open.

(Padmini Sahou): Hi. This is Padmini, I had a question regarding compliance and enforcement. 

So when there is non-conformance that has been identified for distributed 

products, we usually have the ETT, or the health risk assessment form that 

FDA requires. I was just wondering if there would be an additional risk 

benefit assessment form that would be required or with this guidance 
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document being published is there an additional requirement for companies to 

provide their current risk files when reaching out to FDA during enforcement 

decision making?

Ann Ferriter: So this guidance document does not add an additional requirement to provide 

additional information. You mentioned the HHE (Health Hazard Evaluation)

form. Our vision is that over time we'll modify the HHE form to incorporate 

benefit so that you could see how FDA considers it in our health hazard 

evaluations.

(Padmini Sahou): Will that be in line with this guidance document in the future like...

Ann Ferriter: Yes.

(Padmini Sahou): And being from a regional diagnostic industry, I'm not sure, like, what patient 

perspective. I don't think we have that much of information. It's really the 

information from, I would say, the physician setting, or the clinical setting 

about, you know, them making an assessment about the benefits rather than 

the actual patient perspective. Would you have any advice on that because we 

have, like, you know, medical affairs personnel or, like, someone at that 

position making this assessment of how beneficial or how much risk would a 

non-conforming device boast to a patient, but not really having a perspective 

from the patient itself.

Ann Ferriter: Right. And this would be a device-by-device analysis that you would do. But 

there will be some devices that there isn't a strong signal from a patient 

perspective. We understand that.

(Padmini Sahou): Okay.
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Coordinator: Our next question comes from (Debbie Connors). Go ahead, your line is open.

(Debbie Connors):Thank you very much. Ann, thank you for the presentation. And just looking 

at what you've gone through on the slide deck, it appears that the guidance 

talks a lot about the what's of the information that FDA considers in this 

decision-making process.

What I'd like to understand a little bit more is how does FDA once you've 

gathered all of this data, how do you rank it and how do you aggregate it as 

part of your analysis and decision-making process for whether a violative 

product should stay in the field or what action should be taken against a 

manufacturer?

Ann Ferriter: So I think that's next step. We've got a lot of questions, a lot of comments on 

the guidance about how were different factors weighted and what was the 

ranking of different factors. And we don't have all those answers yet.

What we've done now is standardized the factors for consistency and create 

the detailed worksheets so you can see our thought process. But the actual 

ranking and any kind of algorithm that would help us establish whether 

something should have non-regulatory or regulatory approach has not been 

developed yet. And we're working with ORA and OIR to get all of that.

(Debbie Connors):Can I ask a follow-up?

Ann Ferriter: Yes.

(Debbie Connors):Is that an activity that you will be piloting as well? And are you going to 

within industry look at examples within industry when you pilot that?
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Ann Ferriter: I would say yes. I can't commit all of our FDA resources, but I think piloting 

within an industry would have significant benefits.

(Debbie Connors):Thank you.

Coordinator: I show no additional questions at this time. But as a reminder, if you would 

like to ask a question, please unmute your phone, press star 1 and record your 

name clearly when prompted so I may enter it with your question. Again, star 

1 to ask a question. One moment please for incoming questions.

I show no additional questions at this time. I'd like to turn the call back to 

Irene Aihie.

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

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

available on the CDRH Web page at www.fda.gov/training/cdrhlearn. That's 

Friday, February 17.

If you have additional questions about the final guidance document, please use 

the contact information provided at the end of the slide presentation. As 

always, we appreciate your feedback. Please complete a short survey related 

to today's webinar. The survey can be found at fda.gov/cdrhrwebinar. Again, 

thank you for participating. This concludes today's webinar.

Coordinator: This concludes today's conference. Thank you for participating. You may 

disconnect at this time.

END