FDA Webinar

Moderator: Irene Aihie 

10-31-17/12:00 pm ET 

Page 1 

FDA Webinar- Evaluation and Reporting of Age, Race, and 

Ethnicity Data in Medical Device Clinical Studies

Moderator: Irene Aihie

October 31, 2017 

12:00 pm ET 

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

listen-only mode until the question and answer session of today’s conference. 

At that time, you may press Star 1 on your phone to ask a question. 

I would like to inform all parties that today’s conference is being recorded. If 

you have any objections, you may disconnect at this time. 

I would now like to turn the conference over to Ms. Irene Aihie. Thank you. 

You may begin. 

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

Office of Communication and Education. On September 12, 2017 the FDA 

issued the final guidance document, Evaluation and Reporting of Age, Race, 

and Ethnicity-Specific Data in Medical Device Clinical Studies. The data 

provides recommendations to improve the quality, consistency, and 

transparency of data on how medical devices perform in specific age, race, 

and ethnic groups. Proper evaluation and reporting of this data to benefit 

patients, physicians, researchers, and regulators. 
FDA Webinar

Moderator: Irene Aihie 

10-31-17/12:00 pm ET 

Page 2 

Today, Katie O’Callaghan, Assistant Director of Strategic Programs in the 

Office of the Center Director, and Katherine Kim, a Consumer Safety Officer 

in the Office of Compliance here in CDRH will present an overview of the

final guidance. 

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

to information provided during the presentation. 

Additionally, there are other subject matter experts here with us today to assist 

with the Q&A portion of our webinar. Now, I give you Katie.

Katie O’Callaghan: Hi. Good morning. This is Katie. I am from the Center Director’s Office here 

at CDRH and my group is responsible for: leading the Center’s efforts on 

patient engagement, patient preferences, patient reported outcomes; for 

increasing the impact of our regulatory science activities across the Center; for 

connecting our experts with experts outside of FDA, and we also play a key 

role in efforts around diversity in clinical trials. 

I’ll provide a few remarks on the backgrounds and the origins of this guidance 

and then I will turn it over to Katherine Kim who served as the lead author for 

this guidance during the detail in my office. 

So the origins of this guidance go back to the Food and Drug Administration 

Safety and Innovation Act or FDASIA, which was signed into law in 2012. In 

FDASIA there was a section 907, which directed the agency to examine the 

participation of diverse subgroups with respect to age, race, ethnicity, as well 

as sex and gender, and to evaluate the corresponding data the FDA was seeing 

in medical product submissions and whether this information was 

subsequently being made available to the public. 
FDA Webinar

Moderator: Irene Aihie 

10-31-17/12:00 pm ET 

Page 3 

We evaluated our submissions and issued a report in 2013 which was made 

available to the public as well as to Congress and also an action plan in 2014. 

The action plan in 2014 provided a variety of recommendations and actions 

that the agency would take in order to improve the participation, quality, and 

transparency of medical product performance in age, race, and ethnicity 

subgroups. And this guidance was a commitment that we made under that 

plan. 

In forming the recommendations in this guidance, we got input from experts 

and stakeholders as well as the public through a variety of public fora, 

including a workshop organized in 2015 by the Institute of Medicine. Draft 

guidance was issued in June of 2016 and we incorporated changes in response 

to public feedback we received and issued the final guidance which went into 

effect September 12, 2017. 

In the report which was issued in 2013, we evaluated for CDRH 37 original 

premarket approval or PMA applications that had been approved in a prior 

year. This included 46 pivotal clinical studies. We looked for demographic 

variables on sex, age, race, and ethnicity subgroups. 

And the documents we considered were the PMA applications submitted by 

industry as well as the publicly available final labeling, the publicly available 

summaries of safety and effectiveness data in which FDA provides an 

overview of the basis of our decision to approve as well as internal 

documentation provide by the review team. 

What we found in fact there was a need for improved consistency in our 

analysis as well as in the information that’s made available to the public. 
FDA Webinar

Moderator: Irene Aihie 

10-31-17/12:00 pm ET 

Page 4 

For age groups, 70% of the PMAs which we evaluated included an analysis of 

this data and 57% presented some information in public documents regarding 

age groups. For race and ethnicity subgroups, these numbers were 27% 

analyzed and 16% presented publicly. 

In terms of participation, the participation by age group varied depending on 

the indication. This information if you are interested in looking at some more 

detail can be found in the FDASIA 907 report which was issued in 2013 and 

is available on FDA’s website. We observed a lack of consistency in the type 

of descriptive statistics on age that are reported in PMAs, but we did find that 

age range was most commonly reported. 

Participation by race also varied by indication. In some cases, racial 

composition was consistent with disease prevalence, whereas in other cases it 

did not appear to match prevalence in the disease for the US population. 

And participation by ethnicity varied as well. 

In 2014 as directed by Congress, we issued an action plan which included 27 

actions that the agency would take to address the gaps and issues that we 

found in the 2013 report. These actions fall into three broad categories --

participation, quality, and transparency. 

So, why consider age, race, and ethnicity specific differences? There are 

differences in biology, environment and the interaction between these that 

could affect health, disease, and response to medical devices in different 

groups. For example, radiation emitting devices -- which are regulated by 

FDA -- we know that pediatric patients are more sensitive to ionizing 

radiation exposure. 
FDA Webinar

Moderator: Irene Aihie 

10-31-17/12:00 pm ET 

Page 5 

FDAs decisions are made on the basis of an overall benefit-risk evaluation and 

we know that this benefit-risk profile, as well as other important aspects of 

device performance, can differ across age, race, and ethnic subgroups. Some 

examples listed here include dermatology devices and orthopedic devices, 

which may have different considerations in the different subgroups. 

What about clinical trials? Why is diversity important? We know that there 

has been a historical lack of information in clinical studies about the risks and 

benefits of medical device use in these subgroups. And this is true not only for 

trials that are reviewed by FDA, but it’s also been observed in academic 

research studies. Ideally, clinical trials should aim to include diverse 

populations which reflect the intended population of use whenever possible. 

We also know that there’s an abundance of research and recommendations 

about how to enhance diversity in clinical trials. This has been primarily 

organized and forwarded by groups like the National Institute of Health and 

other academic or community research parties. 

So this guidance provides us an opportunity to raise awareness among the 

medical device industry and associated trial community about these 

recommendations. And with that, I will turn it over to Ms. Katherine Kim.

Katherine Kim: Thank you so much, Katie. Hello everyone. My name is Katherine Kim and 

I’ll be talking about this particular guidance moving forward. 

So the objective of this guidance is to provide recommendations to improve 

the quality, consistency, and transparency of data regarding the performance 

within medical devices within specific age, race, and ethnic groups. And for 

the purposes of simplicity, we’ve abbreviated age, race, and ethnicity to ARE 
FDA Webinar

Moderator: Irene Aihie 

10-31-17/12:00 pm ET 

Page 6 

moving forward. FDA believes proper evaluation and reporting of this data 

can benefit patients, clinicians, researchers, regulators, and others. 

This guidance also includes recommendations and considerations to assist 

sponsors in developing a strategy to enroll diverse populations that reflect 

intended use populations. So the purpose of the objective, there are three main 

ones -- by diverse participation, consistent analysis, and the transparency of 

reporting age, race, and ethnic specific information in summaries and labeling. 

I’ll be providing the scope of the guidance. And this is to improve the quality, 

consistency, and transparency of data regarding the device performance within 

age, race, ethnicity-specific subgroups. This applies to devices that include 

clinical information in support of a marketing submission, and that includes 

(510(k), De Novo request, PMAs, and HDEs. This also applies to postapproval study submissions and post-market surveillance studies. 

As noted, the age, race, and ethnicity guidance builds upon the sex-specific 

final guidance and therefore extends the policy set for in that sex-specific 

guidance to include age, race, and ethnicity.

So next we’ll go to the different types of terminology. There’s a lot of 

subgroups and we want to define what they are. 

When evaluating age-specific data, clinical studies should first plan to group 

age groups as appropriate for the disease condition. For device regulations, 

pediatric population is defined in device regulations as less than 22 years of 

age. Now, FDA does not define a specific age for the geriatric population due 

to different considerations for the wide variety of medical devices and 

diagnostics. 
FDA Webinar

Moderator: Irene Aihie 

10-31-17/12:00 pm ET 

Page 7 

In accordance with FDA’s guidance collection of race and ethnicity data in 

clinical trials, patients may self-identify in both an ethnic and racial category. 

The preferred method is a separate collection of two question formats. Other 

considerations noted that the disease or condition may warrant more granular 

race data and the categories may not be appropriate outside the US and the 

methodology should be clearly defined in the study protocol. 

In the two-question format, this is what the two questions look like. Question 

one is answered first. Do you consider yourself Hispanic Latino or not 

Hispanic Latino? And question two -- which should be answered second -- is 

which of the following five racial designations best describes you? More than 

one choice is acceptable. And you have American Indian or Alaskan Native, 

Asian or Pacific Islander, Black, Hispanic, and White. And these are 

categories per OMB policy directive number 15. 

Next, we’ll get to the meat of the guidance. And they are categorized in three 

main sections. Section four talks about the enrollment of diverse patients. 

Section five talks about the analyze and interpreting the study data. And 

finally, section six talks about submitting and reporting age, race, and 

ethnicity data. 

Each of the recommendations in each of the sections are grouped by different 

stages of development. The first stages are study design and early enrollment 

of clinical studies. The second stage is the premarket submission stage. And 

lastly, you have recommendations for a post-market submission stage. So 

we’ll first tackle section four, enrollment of diverse patients. 

Ideally the plan is to enroll a representative proportion of age, race, and ethnic 

subgroups consistent with the intended use population of the device. You can 

see page 13 for further enrollment resources. 
FDA Webinar

Moderator: Irene Aihie 

10-31-17/12:00 pm ET 

Page 8 

Below are some of the key considerations -- disease incidence or prevalence 

in subgroups, diagnosis and treatment patterns in subgroups, proportions of 

subgroups included in past studies for target indication, and lastly clinically 

meaningful subgroup differences in safety, effectiveness, or overall benefitrisk profile. 

Below are some considerations for enhancing diverse enrollment. Number one 

include investigational sites with access to age, race, and ethnic subgroups. 

Number two, alternative communication strategies for study materials. Three, 

consider broader enrollment criteria. Four, investigate reasons for no or low 

inclusion of age, race, and ethnic subgroups. Five, involve community 

providers and patient advocacy groups in recruitment. Six, compensation for 

transportation costs. 

And lastly, flexible scheduling and child care and elder care. Again, see page 

13 for enrollment resources. There are additional recommendations we have 

on there. 

We also have recommendations to enhance retention. And these are 

categorized by what - considerations to sponsors to consider as well as what 

investigators should consider. So I’ll kind of provide key points, key 

recommendations. 

For the sponsors, recommend that they develop follow-up plan to include 

proxy contact information and actions to take when a patient misses a visit, 

closely monitor follow-up rates so problems can be addressed quickly, and 

report accountability of participants in the study report. 
FDA Webinar

Moderator: Irene Aihie 

10-31-17/12:00 pm ET 

Page 9 

For investigators, stress the importance of follow-up at time of informed 

consent and subsequent visits, provide reminder calls for upcoming visits, 

attempt to locate patients lost to follow-up, record reasons for patient 

withdrawals, and finally, maintain continued interest in patients with post-op 

and follow-up visit calls. Page 19 also has additional approaches to minimize 

loss to follow-up. 

We’ll next go to section five, the analysis and interpretation of study data. 

These are the statistical recommendations that are included for all studies. The 

Statistical Analysis Plan -- also known as SAP -- in the study protocol should 

pre-specify assessment of heterogeneity across relevant demographic 

subgroups. And this may include interaction testing or other approaches. And 

SAP should also pre-specify reporting by demographic subgroups. 

And a lot of this section refers to the FDA guidance evaluation of sex-specific 

data. So please refer to that for additional statistical recommendations. 

When subgroup differences are anticipated, consider proper study design, 

sufficient enrollment of subgroups to allow meaningful analysis, and 

potentially controlling for multiple comparisons. You may also want to 

consider subgroup-specific objective performance criteria -- also known as 

OPC -- or performance goals -- PG. 

You may also consider powering for subgroup-specific claims and may 

consider demographic subgroups as stratification variables in randomization 

process when appropriate. 

Again, please see the sex-specific data guidance for additional statistical 

recommendations. 
FDA Webinar

Moderator: Irene Aihie 

10-31-17/12:00 pm ET 

Page 10

The chart in this figure depicts a series of decision trees that provide a 

framework in deciding when various age, race, or ethnicity specific statistical 

recommendations apply for different clinical study designs. 

Now the FDA encourages the use of existing scientific data to determine 

whether there is a hypothesis for a clinically meaningful demographic group 

specific for your device. And this figure includes a flowchart summary of 

recommendations provided in section five. 

And please refer back to these sections in the final guidance for a detailed 

explanation of these recommendations. 

So this is again another flowchart identifying recommendations for 

demographic subgroup specific statistical analysis for one arm studies. And 

this is the flowchart summary for specific statistical analysis for comparative 

studies. 

Furthermore, here are additional recommendations for analyzing subgroup 

data. Now FDA submissions should include analysis of the following for 

clinically meaningful age, race, ethnicity-specific differences: primary 

effectiveness endpoints, primary safety endpoints, and key secondary 

endpoints. Regardless of the potentially limited statistical power of these 

subgroup analyses, we recommend that you should provide them in your 

submission. 

Other considerations of subgroup analysis -- there’s an understanding that 

inadequate sample size and unplanned subgroup analyses are generally not 

considered adequate for statements in labeling. And sometimes effect can be 

statistically significant but not clinically meaningful and vice versa. We also 

understand that observed heterogeneity can sometimes be explained by other 
FDA Webinar

Moderator: Irene Aihie 

10-31-17/12:00 pm ET 

Page 11

covariates. And furthermore, hypothesis for exploratory analysis should be 

consistent with the literature, such as natural history, subgroups, and known 

pathophysiology. 

Next we’ll go to the interpretation of age, race, and ethnicity specific data. 

And the key question is are there clinically meaningful and/or statistically 

significant differences observed? If so, please discuss with FDA. 

You should also describe how these contribute to overall benefit-risk profile 

in certain subpopulations. Finally, limitations with small data sets or larger 

studies with underrepresentation of diverse subgroups should be discussed 

with the FDA.

Lastly, we’ll talk about section six, submitting and reporting of this data. And 

there’s this I guess for definition purposes like to define submit as to refer to 

information submitted to FDA for analysis. And the term report refers to 

information that should be included in publicly available documents such as 

labeling or FDA review summaries. 

Now, here are the recommendations for submitting and reporting subgroup 

data. And these are divided by both submitting to FDA and what should be 

publicly reported. And these are enrollment demographics for ARE subgroups 

should be for both submitting and reporting. But for submitting it’s also 

important to note differences in relevant baseline characteristics and comorbidities, any disproportionate loss to follow-up, and outcome differences. 

Now, when we’re talking about outcome differences, should publicly report 

clinically meaningful and statistically significant outcome differences. When 

you submit to FDA, please discuss the generalizability of results when 

enrollment is substantially different than the prevalence. 
FDA Webinar

Moderator: Irene Aihie 

10-31-17/12:00 pm ET 

Page 12

And when you publicly report that, should explain how such differences can 

affect the overall benefit-risk profile for certain subgroups. And lastly, the 

results of pre-specified subgroup analysis to support subgroup-specific 

labeling should be both submitted to the FDA and publicly reported. 

Tables or forest plots showing outcomes by demographic subgroups are 

potential options for reporting these outcomes. This is a sample plot generated

for illustrative purposes and do not reflect actual clinical data. 

And lastly, this is another flow chart summary for recommendations provided 

in section six. And please refer to this figure four in the appendix of the below 

summaries that we’ve covered. 

Thank you so much and we’ll take questions at this time. 

Operator: Thank you. We will now begin the question and answer session. If you would 

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

name and company clearly. Your name and company are required to introduce 

your question. If you need to withdraw your question, press Star 2. Again, to 

ask a question, please press Star 1. It will take a few moments for questions to 

come through. Please stand by. 

Katie O’Callaghan: While those of you on the phone are gathering your thoughts, one 

additional item I’d like to point out in regards to the scope of this guidance – 

as Katherine mentioned, PMAs, HDEs, as well as clinical data included in De 

Novo’s and 510(k)s in the premarket domain are in-scope. Also in-scope are 

post-approval studies and post-market surveillance or 522 studies. 
FDA Webinar

Moderator: Irene Aihie 

10-31-17/12:00 pm ET 

Page 13

Some areas that would be out of scope for this guidance would include 

devices which are intended only for certain groups -- for instance, pediatrics. 

And also, we’re aware of course that in vitro diagnostic device studies 

sometimes are conducted on de-identified leftover specimens. In those cases, 

it’s often difficult to identify the demographic information for these 

specimens. And so in those cases, this guidance would not be expected to 

apply. 

For companion diagnostics, this will oftentimes be a case-by-case 

determination. So we recommend that you contact the primary review division 

or branch to discuss. 

Operator: All right. It sounds like we are ready for our first question. Our first question 

comes from (Melody Domurad) with Merit Medical. Your line is open. 

(Melody Domurad): Good afternoon and thank you for this call. My question has to do with data 

from countries outside the US where it is considered not legal to ask for ethnic 

or racial information. We would like to include those countries in our studies 

but what do we do in that circumstance? 

Katie O’Callaghan: Hi. Thank you, Melody for your question. We are certainly aware of that 

limitation. I would direct your attention to page nine in the guidance where we 

do address the recognition of special considerations for outside-of-the-US data 

that would be included. 

I think a recommendation specifically to the case you bring up would be to 

simply make the FDA aware of that limitation and to which country it applies, 

but then to apply the recommendations of this guidance to the other patients in 

your dataset to the extent possible. 
FDA Webinar

Moderator: Irene Aihie 

10-31-17/12:00 pm ET 

Page 14

Does that address your question? 

(Melody Domurad): It does. Thank you very much. 

Katie O’Callaghan: Thank you. 

Operator: Our next question is from (Tim Haring) with De Novo Pharmaceuticals. Your 

line is open. 

(Tim Haring): Hi. Do you have clarification in the guidance about the differential definition 

of the age group for pediatric as compared to the guidance for pediatric waiver 

application? 

Katie O’Callaghan: I do not believe this guidance, which was specific to CDRH, includes 

reference to the waiver guidance. It does include reference to the regulations 

in which the definition for pediatric for medical devices is included. 

(Tim Haring): Thank you. 

Katie O’Callaghan: You’re welcome. 

Operator: And again as a reminder to ask a question at this time, you can press Star 1 

and record your name and your company name. Our next question comes 

from (Rob Nerr) with Zimmer Biomet. Your line is open. 

(Rob Nerr): Hi. I was wondering how the ARE will affect randomization schemes or 

enrollment. So if you’re halfway through the enrollment and you know you’re 

not quite as balanced as you planned to be, should you adjust later on? 
FDA Webinar

Moderator: Irene Aihie 

10-31-17/12:00 pm ET 

Page 15

Katie O’Callaghan: In general, I’ll say the guidance does include recommendations for things 

that you can do if you are already in study enrollment or have a completed 

study. But my recommendation to you would be to contact the review division 

and copy the patient diversity email address you see here on the screen to 

address your specific case.

Operator: Thank you. Our next question comes from (Elizabeth Orr) with Medtech 

Insight. Your line is open. 

(Elizabeth Orr): Hi. Can you hear me?

Katie O’Callaghan: Yes.

(Elizabeth Orr): Okay, good. My question is say someone has attempted to enroll a diverse 

population, but hasn’t been able to get the patients they would need for proper 

representation. At what point would FDA say that they sort of made a good 

faith effort and they can go ahead? 

Katie O’Callaghan: That will depend on the specifics for the device and the condition and to 

what extent prior information indicates that age, race, or ethnic variables will 

have a bearing on outcome. So that would be a discussion that would be had 

with the review division. 

(Elizabeth Orr): All right. Thank you. 

Katie O’Callaghan: Thank you.

Operator: And again as a reminder to ask a question, please press Star 1 on your phone 

and record your name and company. Our next question comes from (Jane) 

with BBA. Your line is open. 
FDA Webinar

Moderator: Irene Aihie 

10-31-17/12:00 pm ET 

Page 16

(Jane): Hello. I have a quick question. I recently worked with one of the sponsors and 

when we told them that we need to collect the basic demographic information, 

including ethnicity and race, they were very hesitant to collect that 

information, saying that they don’t want to label their patients. What do we do 

in that situation? 

Katie O’Callaghan: So the recommendation in this guidance, as well as in the FDA guidance 

on Collection of race and ethnicity data, does recommend that patients selfreport, which is a key principle in this area. If the company has further 

concerns or considerations that we could discuss, I would encourage you to 

contact the review division and copy the CDRH patient diversity email 

address listed here. 

(Jane): Okay. Thank you. 

Katie O’Callaghan: Thank you. 

Operator: The next question comes from (Shomey) with Medtronic. Your line is open. 

(Shomey): I know that it’s a well-known example that drug treatment can affect 

differently in different race, like immunological responses. Did you know any 

well-known examples that different people race react differently to devices?

Like scan or any other thing you can think about. 

Katie O’Callaghan: Yes. Thank you for your question. The guidance does list a number of 

examples for each of the subgroups. There is a publicly available example 

where there were differences observed in particular race and ethnicity 

subgroups for devices used as dermal fillers, where differences in skin 

pigmentation were associated with differences in outcomes and in overall 
FDA Webinar

Moderator: Irene Aihie 

10-31-17/12:00 pm ET 

Page 17

benefit-risk profiles. And I would refer you to the guidance in the sections on 

each of the specific race and ethnicity and age subgroups for additional 

examples. 

(Shomey): Okay. Thank you. 

Katie O’Callaghan: Thank you. 

Operator: The next question comes from (An Wen) with FD. Your line is open. 

(An Wen): Yes. In regards to the 2005 guidance that was published is there any 

difference in reading this particular guidance? 

Katie O’Callaghan: I believe you’re referring to the FDA wide guidance on the collection of 

race and ethnicity data. That guidance was updated and is referred to in this 

guidance. 

The agency-wide guidance primarily focuses on how that data should be 

collected and categorized in datasets and this guidance, which pertains to 

medical devices, also includes recommendations for how to analyze that data, 

how to report it to FDA, how to report it in publicly available documents as 

well as some recommendations about how to achieve diverse enrollment and 

retention. Does that address your question? 

(An Wen): Yes. 

Katie O’Callaghan: Thank you. 

Operator: Our next question is from (Jane Feyl) with the Indiana Institute of 

Technology. Your line is open. 
FDA Webinar

Moderator: Irene Aihie 

10-31-17/12:00 pm ET 

Page 18

(Jane Feyl): Thank you. Hello everybody. I am a librarian at the Indiana Institute of 

Technology in Ft. Wayne, Indiana. This is my first semester of being 

embedded in our medical device classes. And I’d like advice on how I help 

our students locate and evaluate the studies and the complete reports and so 

forth. This is very new to me, so I appreciate any advice you all can give me, 

any hyperlinks. If you can email me I would most appreciate it. Thank you. 

Katie O’Callaghan: (Jane), hi. Thank you for your comment. Are you able to see the slides that 

we’re projecting at the moment?

(Jane Feyl): Yes, I am. 

Katie O’Callaghan: I would recommend that you go there to the link for CDRH Learn. Do you 

see that? It’s the third link on the slide. That includes the information from 

this webinar, but it also includes a wealth of information about regulatory 

background, expectations, slides from other webinars on other topics that may 

be of interest for your work.

(Jane Feyl): Well, thank you. I appreciate your help. Thank you. 

Katie O’Callaghan: My pleasure. Thank you. 

Operator: Thank you. And again as a reminder to ask a question, you can press Star 1 on 

your phone and record your name and company name. One moment please for 

any further questions. We’re showing no further questions at this time. I 

would now like to turn the conference back over to Irene Aihie. 

Katie O’Callaghan: One final comment from FDA. There are several points of intersection 

here with other activities in pediatrics. And so for those of you who may have 
FDA Webinar

Moderator: Irene Aihie 

10-31-17/12:00 pm ET 

Page 19

particular interest in that area, Dr. Vasum Peiris is our Chief Pediatric Medical 

Officer and leads those efforts. 

And as was mentioned in some of the questions, there are some intersection 

points with other activities around race and ethnicity and FDA has an Office 

of Minority Health who leads those efforts as well. And with that I’ll thank 

you all for your attention and I’ll turn it back over to Irene. 

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 Learn web page at www.fda.gov/training/cdrhlearn by 

Wednesday, November 8. 

If you have additional questions about today’s presentation, please use the 

contact information provided the end of the slide presentation. 

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

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

webinar experience. The surveys will be found at www.fda.gov/cdrhwebinar 

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

you for participating and this concludes today’s webinar. 

Operator: That does conclude today’s conference. Thank you again for your 

participation. You may disconnect at this time. 

END