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Pediatric Information for 

X-ray Imaging Device 

Premarket Notifications

Laurel Burk, Ph.D.

Biomedical Engineer

Division of Radiological Health 

Office of in Vitro Diagnostics and Radiological Health

Center for Devices and Radiological Health
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Overview of Today’s Webinar

• Balancing benefits and risks of pediatric radiation exposure 

– Pediatric radiation exposure risks should be balanced with an 

exam’s benefits; we have the opportunity to reduce dose

• Guidance scope

• Guidance overview: 510(k) submission contents for 

manufacturers

– Indications for use

– Device risk assessment

– Features/protocols/testing 

– Pediatric labeling and instructions for use

• Ongoing collaborations to promote pediatric safety

• Questions
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Pediatric Population

• CDRH defines pediatrics as birth through 21 years*

– Age ranges: neonate (birth-1 month), infant (1 month-2 years), 

child (2-12 years), adolescent (12-21 years)

• For X-ray imaging and radiation dose optimization, patient 

size/weight matters more than age

– Smaller patient thicknesses need less radiation to produce a good 

quality image

– Children’s heads grow at a different rate than their bodies, so age 

groupings for head imaging may differ from body imaging

• Guidance suggests size/age ranges for pediatric groupings

*See FDA’s guidance entitled “Premarket Assessment of Pediatric Medical Devices”

(http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM089742.pdf).” 
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Balancing Benefit and Risk

• X-ray imaging helps in the diagnosis, treatment planning, and 

surgical intervention in children

• However, ionizing radiation exposure from X-ray exams may 

slightly increase lifetime risk of cancer. To minimize risks to 

children, imaging should be justified and optimized: 

– Justify: only prescribe X-ray exams when needed to diagnose 

or answer a medical question, and when benefits outweigh 

risks

– Optimize: exams should use techniques for the lowest 

radiation dose that still allows image quality adequate for 

diagnosis / intervention 
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Opportunities to Minimize Risk

• Most X-ray imaging devices can be safely optimized for 

pediatrics

– Many may lack instructions for pediatric use and dose 

optimization use 

– X-ray imaging professionals may struggle to locate and 

apply these recommendations without help from 

manufacturers 

• Pediatric device features can be developed to enhance 

safety and mitigate pediatric-specific risks
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Role of Manufacturers

• Manufacturers can help by following recommendations and 

actions in the final guidance to support health care 

professionals in managing X-ray doses:

– Optimizing for pediatrics by default, including instructions for 

optimization, and including pediatric instructions for use

– Helping their customers encourage reduction of radiation dose 

through educational tools, some examples are available on 

FDA’s Pediatric X-ray imaging webpage

– Developing device features to enhance safety and mitigate 

pediatric-specific risks
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Pediatric Safety is a Shared 

Responsibility

Manufacturers

• Provide safe and effective devices

• Consider pediatric needs and risks in device design – provide and test features

• Include instructions and information for users

FDA

•Assure safety & effectiveness of devices

•Outreach to public / collaborate with stakeholders

Health Care Provider

• Justify – order exams only when necessary

•Optimize – use the right dose for the patient, know and use your equipment’s features

• Communicate benefits and risks with patients and parents

Parents, Caregivers and Patients

• Track the child’s medical imaging history

•Ask the doctor whether the exam will improve child’s healthcare

•Ask facility about safeguards and if the exam is “child-sized”
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Goals for Pediatric X-ray Imaging 

Guidance Document

• Provide guidelines to manufacturers recommending actions 

manufacturers can take to support health care professionals 

in managing X-ray doses for pediatric patients:

– Design and testing of X-ray imaging equipment and features 

should be related to patient size and cover all size ranges

– Equipment should be designed so health care professionals can 

appropriately image smaller patients more easily

• Devices that are designed and labeled for pediatric use will 

help ensure the safety and protection of patients
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Guidance Scope

• Guidance for Industry and FDA

– The guidance provides an opportunity for Industry and FDA to 

discuss pediatric radiation safety with parents, health care 

professionals, and the public

• Information to include in a Premarket Notification [510(k)] 

submission and in device labeling

• X-ray imaging devices and component parts

• Indicated for:

– Pediatric populations, OR

– General use devices, where significant pediatric use is anticipated
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Use of X- ray Devices with Pediatrics

• Most general use X-ray devices have significant pediatric use

– Unless a device’s design explicitly excludes pediatric imaging, we 

know most devices will be used to image children

– In 2006, 10 percent of all CT procedures (60 million annually) were 

for pediatric patients*

– Majority of pediatric exams not done in children’s hospitals; 

equipment used for all patient sizes/ages

*[National Council on Radiation Protection and Measurements (NCRP). Report 160: Ionizing Radiation Exposure of the 

Population of the United States. March 3, 2009.]
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Protocols and Optimization

• “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”

– Clarification language requested by end users, so manufacturers 

are able to respond to customer requests

– See Section XIII (“Protocols”) of the guidance document
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Indications for Use Statement

• Indications for use statement: specify all populations for 

whom device is intended

• If a pediatric population’s needs were specifically evaluated in 

the design and testing, the population should be stated in the 

indications for use

• If a device is intended only for adult use, clearly state this as 

part of the device’s indications for use statement 

– Most general use X-ray devices can be used in pediatrics

– “Not for pediatric use” to be used only when there are physical 

design safety limitations (e.g., extremity-only cone beam CT 

designed for adults without pediatric-sized shielding)
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Include in Your 510(k)

• In your 510(k) submission, address pediatrics in the following 

ways:

– Risk Assessment: Address pediatric use, provide appropriate 

mitigations 

– Protocols: Provide default imaging protocols for pediatric 

subpopulations (different size/weight ranges)

– Testing: Assess device performance across the entire indicated 

patient population size range 

– Labeling: Instructions/info specific to pediatric use; include a 

Pediatric Summary section
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Risk Assessment

• Consider all foreseeable risks for all applicable populations

• Your device will be used on children – this is foreseeable

• Hazards may differ for patients of different sizes

• Consider hazards that can cause low image quality or 

unnecessary dose for children:

– Use of adult protocols or settings instead of pediatric-specific 

– Design that prevents proper positioning of pediatric patients

– Absence of safety features to block radiation to other anatomies

• Mitigations may include pediatric design features/labeling

– If assessment result does not require the above, provide 

justification 
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Performance Testing 

• Performance testing should cover full indicated patient size 

range (neonate to adults)

– For tests with size dependence, test largest and smallest 

sizes; for others, test all size ranges

• Justify why conditions are applicable to full patient size range

• Settings used in testing should represent typical clinical use

• Summarize test conditions and results

• Images will be required only when laboratory testing is 

insufficient to demonstrate safety and effectiveness, and when 

extrapolation from adult images is not sufficient
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Pediatric Summary Section

• X-ray devices for which significant pediatric use is 

anticipated should include a Pediatric Summary section

• The Pediatric Summary section of the labeling / user 

manual contains:

– A description of any special pediatric features and labeling 

information for pediatric use of the X-ray imaging device

– Appropriate pediatric cautions/warnings and instructions for use 

for the specific device type

– The following caution statement: “Use special care when 

imaging patients outside the typical adult size range” 

• The guidance features a sample summary in appendix A
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Protocols – Across All Sizes

• The term “Protocol”, as used in the final guidance, is set of any 

programmed technical factors, control functions and settings, 

including image processing settings, designed to optimize the 

image acquisition and display

• Provide pediatric-appropriate protocols for common procedures, 

adjusted for the patient's size/weight

• Include a list of all available pediatric protocols (downloadable 

electronic format) with the following info:

– Protocol, and exam name/purpose

– Anatomical region

– Patient size/weight range

– Acquisition parameters

– Representative dose information (appropriate to pediatrics)
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Ongoing Pediatric Collaborations

• Cooperation among industry, clinicians, physicists and regulators for 

many years

• Initiative to Reduce Unnecessary Ionizing Radiation from Medical 

Imaging resulted in

– Four computed tomography industry standards

– New equipment that is used for calibration and testing purposes 

(phantoms) for quantitative dose reduction measurements

• Resulted in updates to International Electrotechnical Commission (IEC) 

standards

• Size specific dose estimate: a better way to estimate dose across all 

patient sizes will become a new IEC standard

• Upcoming work – dental X-ray standards 
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Communicating with the Public:

Information, Not Alarm

• Remember the benefits, balance the risks

– When medically justified, benefit of exams far outweigh 

radiation risk 

– Parents, caregivers and patients should ask questions about how 

the exam will improve the patient’s health care and the risks 

involved 

– Cancer risk estimates are uncertain but low; optimizing 

radiation dose to lowest needed level will minimize this risk
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• FDA Resources:

– Pediatric X-ray Imaging webpage 

– Initiative to Reduce Unnecessary Radiation Exposure from

Medical Imaging

– FDA Voice Blog: X-rays and Children: FDA Issues Guidance to

Minimize Dose

– Medscape Article: Safety in Pediatric Imaging: FDA Releases

New Guidance 

Opportunities for Public Communication