FDA 

Moderator: Irene Aihie

01-09-18/3:00 pm ET

Page 1

FDA Webinar: Pediatric Information for X-ray

Imaging Device Premarket Notifications: Final Guidance

Moderator: Irene Aihie

January 9, 2018

3:00 pm ET

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

listen-only mode until the question-and-answer session. If you would like to 

ask a question today please press star followed by 1 on your touch-tone phone. 

At that time you will be prompted to record your first and last name.

The conference is being recorded today. If you have an objection, you may 

disconnect at this time. Now I will turn the call over to your host, Ms. Irene 

Aihie. Thank you. 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 November 27, 2017 the FDA 

released a final guidance encouraging manufacturers to consider radiation 

safety of pediatric populations in the design of X-ray imaging devices.

The purpose of the guidance is to provide industry with recommendations on 

the information that should be included in premarket submissions for X-ray

imaging devices that may be used on pediatric patients. 
FDA 

Moderator: Irene Aihie

01-09-18/3:00 pm ET

Page 2

These recommendations include pediatric youth instruction, safety 

information and a description of available pediatric-specific features which 

will help healthcare professionals to make more informed decisions about the 

use of the device on pediatric patients.

Today Laurel Burk, Biomedical Engineer in the Office of In Vitro Diagnostics 

and Radiological Health here in CDRH, will present an overview of the final 

guidance. 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 speak to the Q&A portion of our Webinar. Now, I give you Laurel.

Laurel Burk: Thank you for that introduction, Irene. I want to start today’s Webinar by 

discussing the motivation of this guidance document which is to recommend 

ways that manufacturers can promote a balance between the benefits of X-ray

imaging and the possible risks of radiation exposure to pediatric patients.

Because we have an opportunity to reduce risk by reducing unnecessary dose 

to children, FDA has introduced this final guidance document. We’ll discuss 

the guidance document contents in more detail starting with the scope and the 

types of medical devices that the guidance applies to.

We’ll provide an overview of the specific 510(k) premarket notification 

submission content that are discussed in this guidance document like the 

indications for youth statements, the device risk assessment as it applies to 

pediatric use, pediatric features and the testing we need to support their use 

including a full range of patient sizes from the smallest children and labeling 

and instructions for use.
FDA 

Moderator: Irene Aihie

01-09-18/3:00 pm ET

Page 3

We’ll then discuss ongoing collaborations among FDA, industry, medical 

professionals and professional societies who are all working together to

promote pediatric safety and X-ray imaging. And at the end, we’ll save plenty 

of time for your questions.

To start let’s first define pediatric populations. The Center for Devices and 

Radiological Health defines pediatrics as birth through age 21 with 

breakdowns into different pediatric subpopulations based on different age 

ranges. But for X-ray imaging and radiation dose optimization, it’s especially 

important for us to think about the patient’s size or weight.

Smaller patients with smaller body thicknesses typically need less radiation to 

produce a good quality image. Because of this, FDA encourages 

manufacturers to divide pediatric subgroups for their protocols based on size 

or weight, not just age.

Since children’s heads grow at a different rate than their bodies, appropriate 

age groupings for head imaging won’t necessarily be the same as those for 

body imaging. Our guidance document suggests some size and age ranges for 

pediatric grouping for body imaging and for head imaging, keeping in mind 

that the patient’s size or thickness is the most important factor for imaging and 

dose optimization.

Our motivation for this guidance document is to let manufacturers know how 

they can better support healthcare providers in balancing the benefits and risks 

of X-ray imaging with pediatric patients. As we know, X-ray imaging is often 

necessary for diagnosis, treatment planning and surgical intervention in 

children.
FDA 

Moderator: Irene Aihie

01-09-18/3:00 pm ET

Page 4

However, ionizing radiation exposure for X-ray exams could slightly increase 

lifetime risk of cancer. Although this is a small risk, we should try to 

minimize it as much as possible, and to do this we encourage imaging to be 

justified and optimized.

Justification means performing X-ray exams only when needed to diagnose a 

disease or to answer a medical question and when the benefits are believed to 

outweigh the possible risks. Optimization means performing that necessary 

exam using techniques with the lowest radiation dose that will still result in 

adequate image quality so that the image can be used for diagnosis.

Appropriate justification is the responsibility of medical professionals who 

order and perform X-ray imaging exams. Optimization however is an area 

where other experts and stakeholders like manufacturers can make significant 

contributions.

We want to take any opportunity we can to minimize risk from X-ray scans of 

pediatric patients. Most X-ray imaging devices in use today can be safely 

optimized for imaging children, but we’ve heard from healthcare providers 

that many of these devices lack clear instructions for pediatric use or 

instructions on how to optimize dose.

There are expert organizations who offer training materials and 

recommendations for dose optimization and radiation safety in pediatrics but 

imaging professionals may have difficulty locating and applying these 

recommendations without some extra support from manufacturers.

In addition you as the manufacturer are in the best position to understand what 

specific features can be applied to your imaging devices to enhance the safety 
FDA 

Moderator: Irene Aihie

01-09-18/3:00 pm ET

Page 5

of pediatric use and to mitigate pediatric-specific risks that could occur from 

inappropriate use of your device.

Manufacturers can help support healthcare providers by following the 

recommendations and actions listed in the final guidance. You can ensure that 

your devices are optimized for pediatrics by default or with an easy setup,

providing instructions for optimization and including pediatric instructions for 

youth.

You can help customers to optimize exams for children by promoting and 

providing educational tools developed by expert organizations, and we 

provide links to some of these educational tools on our newly-updated 

pediatric X-ray imaging Webpage on FDA’s Website. Finally, you can 

develop device-specific features which enhance safety and mitigate pediatricspecific risks. 

Of course, we can’t forget that pediatric safety is a shared responsibility. 

Manufacturers’ roles are discussed on the last slide and will be the focus of 

much of the rest of this talk but FDA, healthcare providers and patients and 

parents will work with you on the shared goals.

FDA’s mission is to assure the safety and effectiveness of devices for all 

populations including children. We have issued our guidance document to 

support this goal. We also have the opportunity for public outreach in 

collaboration with stakeholders which we’ll mention at the end of this 

presentation.

Healthcare providers are on the front lines. They are the ones prescribing and 

performing exams and they can practice those principles of justification and 
FDA 

Moderator: Irene Aihie

01-09-18/3:00 pm ET

Page 6

optimization in their practices to protect children. Also, they can clearly 

communicate the benefits and risks of exams with patients and parents.

Finally, parents, caregivers and patients have a role to play. They can track a 

child’s medical imaging history and ask questions like whether an exam will 

improve their child’s healthcare or whether the exam has been correctly childsized. Again, these are the justification and optimization questions we’ve 

mentioned a couple of times.

The goal of this guidance is to provide manufacturers with recommendations 

on the information that they should include in pre-market submissions or 

510(k)s for X-ray imaging devices that may be used on pediatric patients.

We want manufacturers to design and test equipment and features across the 

full indicated size range including smaller pediatric patients, and we want 

equipment to be designed so that healthcare professionals can easily image 

smaller, younger patients with the appropriate child-sized exam.

We believe that if devices are designed, tested and labeled for safe and 

effective use in the pediatric population, they will be safe and effective for 

everyone. Now I’ll discuss the contents of our final guidance in some more 

detail. This guidance is for industry and FDA and it covers the information 

that should be included in a 510(k) submission and in a device’s labeling.

The guidance applies to X-ray imaging devices and to component parts such 

as detectors and some software. These are recommendations that 

manufacturers should follow when they are ready to market a new device or 

when they submit their next 510(k) for modifications to a currently-marketed 

device.
FDA 

Moderator: Irene Aihie

01-09-18/3:00 pm ET

Page 7

It applies to devices which are indicated either specifically for pediatric 

populations or for general use devices where significant pediatric use is 

anticipated.

X-ray

So, a little more about that last point. Most general use X-ray devices will 

have significant pediatric use. Unless a device is designed explicitly exclude 

safe pediatric imaging, we know most devices will be used on children and the 

number of exams performed annually on pediatric patients is quite significant. 

For example, by one estimate 10% of PT procedures are performed on 

pediatric patients.

Also, most pediatric exams are not performed in dedicated children hospitals 

but are done in community hospitals and general practices with equipment 

that is used for all patient sizes. This is why it’s important for manufacturers 

of general use X-ray imaging devices to follow the guidance’s 

recommendations as well.

We inserted one clarification sentence in the guidance document at the request 

of some end users and it was hard to find a good place to insert this in the 

presentation but I did it here, so I’ll read the sentence in its entirety.

“For previously 510(k) cleared X-ray imaging devices, optimization of 

imaging parameters and provision of pediatric-specific protocols by 

manufacturers solely at the request of end users generally does not by itself 

necessitate submission of a new 510(k) submission.” This is a very long 

sentence which was honed by our lawyers so I’ll repeat the main takeaways.

If a customer reaches-out to you, the manufacturer, asking for individual help 

to optimize pediatric protocols or parameters, you can help without worrying 
FDA 

Moderator: Irene Aihie

01-09-18/3:00 pm ET

Page 8

whether you need to submit a new 510(k) as a result. For more on this long 

sentence, you can refer to the protocol section of the guidance document.

A little bit about the indications for use statement of your device. The 

device’s IFU statement should specify all populations for whom the device is 

intended. If a pediatric population or subpopulation’s needs were specifically 

evaluated in the design and testing of the device, then the population or 

subpopulation should be clearly stated in the indications for use.

If a device is truly intended only for adult use, then this should also clearly be 

stated in the device’s IFU statement. However, as we discussed earlier most 

general use X-ray devices can and will be used for pediatric patients if 

appropriate parameters and protocols are used.

So the language not for pediatric use should be reserved for the IFUs for 

devices only where there are physical design safety limitations preventing 

safety from children so one example could be an extremity-only cone beam 

CT which is designed for adults and adult-sized limbs and where pediatric size 

shielding isn’t included.

The 510(k) submission should include pediatric populations anywhere 

applicable including in the following sections: the risk assessment, protocols, 

performance testing and labeling and instructions for use. On the next slide 

we’ll look at each of these areas in some more detail.

A device risk assessment or hazard analysis should consider all foreseeable 

risks for all applicable populations. Because nearly all X-ray imaging devices 

will be used on children except for those excluded by design and excluded in 

the IFU, pediatric patients and pediatric-specific risks should be included in 

the device’s risk assessment.
FDA 

Moderator: Irene Aihie

01-09-18/3:00 pm ET

Page 9

Consider that hazards may be different for patients of different sizes including 

different pediatric subpopulations like neonates versus adolescents. Also 

consider hazards that could result in low image quality or unnecessary 

radiation dose in children such as use of adult protocols or settings instead of 

pediatric-specific protocols or settings.

The device design prevents proper positioning of pediatric patients or the lack 

of safety features to block radiation to other anatomies. To mitigate any risks 

you find, you may choose to include pediatric-specific design features which 

we strongly encourage or additional labeling and instructions for use in some 

cases.

If you complete a pediatric risk assessment and you determine that you don’t 

need to include the specific features or labeling to mitigate risk, then you 

should please justify this in your 510(k). 

The performance testing of your device and its features should cover the full 

indicated patient size range which for pediatrics can range from small neonate 

to older pediatric patients who are similar to an adult size. If a specific test 

has a well-understood or linear size dependence, then you could provide tests 

for just the largest and smallest sizes with a justification.

For other tests where the size dependence of the results is not as well 

understood, your submission should include testing which covers all of the 

patient size ranges. Your test should include a justification of why the chosen 

test conditions are applicable to a full patient size range.

The settings used in testing should represent a typical clinical use and your 

test report should summarize the conditions and results and how they support 
FDA 

Moderator: Irene Aihie

01-09-18/3:00 pm ET

Page 10

substantial equivalence in the device’s intended use. For many X-ray imaging 

devices and device changes, FDA typically requests sample clinical images to 

be provided with the 510(k) to support substantial equivalence.

However, FDA doesn’t typically request sample clinical images of pediatric 

patients due to the potential risks that could be involved in imaging children 

with devices that aren’t yet cleared by FDA. In those cases we encourage the 

use of imaging phantoms or extrapolation from adult images if possible.

We’ll only ask for images of pediatric patients for a 510(k) when the bench 

testing isn’t sufficient to demonstrate safety and effectiveness and when 

extrapolation from adult images is also not sufficient. 

An important new feature described in the final guidance is the requirement 

for a pediatric summary section in the device’s user manual. XX-ray devices for which 

significant pediatric use is anticipated not just those indicated explicitly for pediatrics should 

include a pediatric summary section. The pediatric summary section contains 

A description of any special features and labeling information for pediatric use of the X-ray

imaging device, appropriate pediatric cautions and warnings and instructions for use for the 

specific device type, and the following caution statement “use special care when imaging 

patients outside the typical adult size range.” 

The guidance document includes a sample pediatric summary section in 

Appendix A including examples both for when specific pediatric features exist 

for the device and for when no specific pediatric features are included. 

Finally let’s discuss the sample protocols that are asked to be provided with 

X-ray imaging devices in device components.

The term protocol means the set of any program technical factors, control 

functions and settings including image processing settings designed to 
FDA 

Moderator: Irene Aihie

01-09-18/3:00 pm ET

Page 11

optimize the image acquisition and display. In your 510(k) submission please 

provide pediatric-appropriate protocols for common procedures adjusted for 

the patient’s size or weight.

You should include a list of all available pediatric protocols for your 

customers in downloadable electronic format with the following information: 

the protocol and exam name and purpose; the anatomical region; a patient’s 

size-weight range; acquisition parameters and representative dose information.

So that covers the content of the guidance document and we answer more 

specific questions in detail at the end but I’d like to discuss some ongoing 

pediatric collaboration and acknowledge the results of hard work done in the 

medical imaging community to improve the safety of pediatric patients.

Since the draft guidance document was published, we’ve seen significant 

cooperation among industry, clinicians, businesses and regulators on this 

issue. This cooperation has driven innovation in pediatric safety features.

In 2010 FDA launched the initiative to reduce unnecessary ionizing radiation 

for medical imaging. In public meetings associated with this initiative and for 

the draft version of this guidance, we heard from physicists and clinicians that 

there were significant gains needed in the availability of pediatric safety and 

radiation safety features and information in X-ray imaging devices.

Since then, industry has been working alongside other stakeholders to develop 

many new updated consensus standards addressing radiation safety features 

for specific types of X-ray imaging devices such as NEMA standards for CT 

devices and IEC standards for fluoroscopy. 
FDA 

Moderator: Irene Aihie

01-09-18/3:00 pm ET

Page 12

We specifically want to call-out a collaboration that took place between the 

Medical Imaging Technology Alliance and the Image Gently Alliance which 

led to the important white paper titled “Essential Questions for Consideration 

in the Design of Interventional X-ray Equipment Entended for Pediatric Use.”

The standards development efforts continue today with FDA involvement. 

For example IEC is working on a new design standard for CT size-specific 

dose estimates which is a better way of estimating radiation dose across a 

range of patient sizes including smaller pediatric patients.

We anticipate new updates to standards for dental X-ray imaging devices in 

the future and that will further enhance the safety of these devices for all patients. FDA 

continues to support industry and healthcare experts as they develop new consensus standards.

We believe that by developing and adopting these standards, manufacturers can ensure that 

cutting-edge pediatric features continue to be developed and available in all X-ray imaging 

devices.

I wanted to close with a few final comments on the responsibility that we 

stakeholders share in communicating responsibly with the public about 

radiation in children. When communicating with the public, our goal is 

always to provide information but not to cause unnecessary alarm.

The cancer risk estimates from radiation exposure are uncertain but low and 

optimizing radiation dose to the lowest necessary level will minimize this risk. 

However, because the public may not be as familiar with epidemiological 

estimates and statistics, quoting numbers may not help parents understand the 

relative risks like we think they will.

For example, Dr. Donald Frush of the Society of Pediatric Radiology has said 

that when parents hear a phrase like “1 in 1000 risk of cancer,” this can be 
FDA 

Moderator: Irene Aihie

01-09-18/3:00 pm ET

Page 13

interpreted as “my child and 999 other people’s children” and this sort of 

interpretation may create unnecessary and unwarranted alarm.

Because of this communication challenge, it can be more beneficial to discuss 

the benefits of the exam and how the X-ray will help care for the child. 

Instead of repeating numbers, you can explain the different types of possible 

risks such as cancer, tissue effect and non-radiation risks, and explain if 

appropriate that the risks are small in comparison with the benefit offered by 

the exam.

We know this type of communication is difficult even for experienced 

healthcare providers so we encourage you to consult resources on the topic 

from the American Academy of Pediatrics, the Image Gently Alliance and

other organizations who are dedicated to promoting the safety of children and 

communicating with the public on these issues.

FDA has had many opportunities for public communications with this final 

guidance document including public blogposts, a Medscape interview, updates 

to our FDA Webpages and this very Webinar.

We encourage you to take this opportunity to responsibly and accurately 

communicate the benefits and risks of X-ray exams in pediatric patients 

because we’re all working together on this shared goal. We now have lots of 

time for your questions. 

Coordinator: Thank you. If you would like to ask a question, please press star followed by 

1 on your touch-tone phone. You’ll be promoted to record your first and last 

name and called-on at your turn. If you decide to withdraw your request, 

please press star followed by 2. One moment, please, for parties to queue-up.
FDA 

Moderator: Irene Aihie

01-09-18/3:00 pm ET

Page 14

Laurel Burk: What are the differences between the draft version of the guidance that was 

published a few years ago and this final guidance? I think there’s three main 

issues that I’d like to point-out. 

The first is the draft guidance encouraged manufacturers who weren’t 

providing detailed testing for pediatric populations to put the language “not 

for pediatric use” on their IFU statement and we’ve heard from stakeholders 

that labeling X-ray devices as not for pediatric use could be misleading since 

most of these devices could safely be used in pediatric populations if the right 

settings and protocols are used that are appropriate for children.

So instead we’re encouraging manufacturers to use the testing 

recommendations in our guidance document and to indicate their devices for 

pediatrics. But if they choose not to, then we really only want them to say “not 

for pediatric use” if it’s actually unsafe to use the device for pediatric use. but 

we do strongly encourage manufacturers to provide pediatric features and to 

test and to provide good instructions for use.

A second difference is that we recommend manufacturers to consider pediatric 

use in their risk framework, their device risk analysis as I mentioned earlier in 

the presentation and to use this risk analysis as the basis for determining 

whether and how to include pediatric-specific features in their device.

And last we heard that it would be helpful to have a dedicated section in user 

manual of pediatric summary which summarizes all of the pediatric features, 

pediatric-specific labeling and instructions for use. 

And we believe that this will allow healthcare providers to easily access and 

understand all of the features and safety information that’s applicable to 
FDA 

Moderator: Irene Aihie

01-09-18/3:00 pm ET

Page 15

pediatrics so they can appropriately optimize their patients’ exams without 

having to hunt around for this information .

So we’ve got another question. Is FDA encouraging facilities to stop using 

their old equipment and purchase new equipment that has pediatric safety 

features? FDA isn’t suggesting the facilities immediately replace their older 

equipment because as we mentioned imaging professionals can safely use the 

equipment that they have right now even if it doesn’t have those instructions 

for use.

But we really encourage healthcare professionals to refer to guidelines and 

advice provided on our pediatric X-ray imaging Website for help in using 

their current equipment to optimize for pediatrics.

And we also refer to educational materials available from the American 

Association of Physicists in Medicine, the American College of Radiology, 

Image Gently Alliance and the World Health Organization among others. Our 

Website links to a lot of those resources. 

Irene Aihie: Operator, do we have any questions?

Coordinator: There are no questions. Thank you. I’ll turn it back over to you.

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 Webpage at www.fda.gov/training/cdrhlearn by 

Wednesday, January 17. 
FDA 

Moderator: Irene Aihie

01-09-18/3:00 pm ET

Page 16

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 live Webinar, 

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

experience.

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.

Coordinator: Thank you. This does conclude the call and you may disconnect your lines at 

this time. Speakers, please standby for your post-conference.

END