How To Get Your Electronic Product 

on the U.S. Market 

Lowell Howard, PhD 

Electrical Engineer 

Office of Radiological Health 

Office of Product Evaluation and Quality 

Center for Devices and Radiological Health (CDRH) 

U.S. Food and Drug Administration 
Electronic Radiation - Emitting Products 

• Homes: TVs, microwave ovens, DVD/Blu - ray 

players, cell phones and wireless devices 

• Airports: Body and baggage security screening 

• Entertainment: Laser Light Shows

• Hospitals: X - ray machines, surgical lasers, 

ultrasound, MRI, and radiation therapy 

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Learning Objectives

1. Explain why FDA regulates electronic products. 

2. Define key terms, roles, and examples for 

manufacturers, products, and components. 

3. Discuss performance standards, manufacturer’s 

certification, and reporting requirements. 

4. Describe methods to communicate with FDA.

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Why Does FDA Regulate 

Radiation - Emitting Electronic 

Products?

FDA’s mission: Protect the public from hazardous 

or unnecessary exposure to radiation from 

electronic products 

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FDA’s Authority

• Federal Food, Drug, and Cosmetic Act (FD&C Act) 

– Electronic Product Radiation Control (EPRC) provisions 

– Sections 531 – 542 

• Code of Federal Regulations (CFR) 

– Title 21, Parts 1000 – 1050 

• Applies to Manufacturers only

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Key Terms, Roles, and 

Examples

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Manufacturer

• Any person (or company) who manufactures, 

assembles, or imports electronic products 

Note: Dealers and distributors are responsible for 

recordkeeping

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Electronic Product

• Any manufactured or assembled product 

– or component, part, or accessory 

• Contains an electronic circuit and 

• Emits electronic product radiation 

– or would emit without effective shielding/controls

Ø Any electrically-powered product that emits radiation

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Electronic Product Radiation

• Ionizing or non - ionizing electromagnetic or 

particulate radiation OR 

• Sonic, infrasonic, or ultrasonic wave 

– emitted from electronic product 

– due to electronic circuit

Ø Any form of machine - produced radiation

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Examples of Non - medical and Medical 

Electronic Radiation-Emitting Products

Non-medical Products Medical Devices

• Microwave ovens 

• Laser pointers 

• Police speed radars 

• Airport security scanners

• Diagnostic x - ray equipment 

• Surgical lasers 

• Lithotripters 

• Tanning beds

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Both Electronic Product and 

Medical Device?

• Must comply with both: 

– FDA medical device requirements 

– FDA radiation safety requirements 

• FDA Medical Device Requirements 

– Register establishment 

• Foreign firms: register the U.S. Agent 

– List medical devices 

– Submit premarket notification or approval application

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Components

• 21 CFR 1020.30: X - ray equipment components 

– Controls, tables, image receptors and others 

– Subject to performance standards 

– Certify and report to FDA

• 21 CFR 1040.10: Laser Products

– Components or replacement parts 

– Laser performance standard not applicable 

• if labeled and status reported to FDA

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Performance Standards and 

Certification

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Radiation Safety 

Performance Standards

• Mandatory for many radiation - emitting electronic 

products/devices 

• Establish requirements 

– design, testing, and labeling 

• Protect public from radiation emissions 

• Codified in 21 CFR 1010 – 1050

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Standards Apply to Range of Products

• Microwave Ovens 

• Lasers 

• Sunlamps/tanning products 

• High - intensity Mercury Vapor 

Discharge Lamps 

• Therapy Ultrasound 

• Television receivers/monitors 

– only cathode ray tube type 

– not LCD, LED, flat panel 

• Cabinet X - ray systems 

• Diagnostic X - ray systems/major 

components 

– radiographic 

– fluoroscopic 

– computed tomography (CT) 

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Electronic Product Certification

• Comply with all applicable performance standards 

prior to marketing in U.S. 

• Certified by manufacturer 

• Based on manufacturer’s quality control testing 

program 

– shows product complies with applicable standard

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Electronic Product Certification

• Certification does NOT indicate FDA 

clearance/approval 

• Self-certification by manufacturer only

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Reporting Requirements

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Reporting Requirements

• Manufacturers must submit reports to FDA 

describing: 

– manufacturer 

– product radiation safety specifications 

– product labeling 

– quality control testing program 

• Report describes how product complies with 

performance standard

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Reporting Requirements

• 21 CFR 1002 

– specific reporting and recordkeeping requirements 

– product, supplemental and/or abbreviated reports 

• Submitted to FDA before the product is 

introduced to U.S. market

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Annual Reports (21 CFR 1002)

• Describe annual production, compliance testing 

results, radiation concerns, and user safety inquiries 

• Due each September 1st for prior reporting period from 

July 1 - June 30 

– Example: September 1, 2019 for period of July 1, 2018 – 

June 30, 2019 

• Valid for one year

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Three Ways to Report to FDA

1. Prepare and submit electronically 

2. Prepare electronically, and email or mail 

3. Prepare hard copy, and email as .pdf or mail 

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1. Prepare and Submit Your Report 

Electronically

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• Prepare report electronically using FDA's free 

eSubmitter software: 

www.fda.gov/ForIndustry/FDAeSubmitter/default.htm

Prepare/Submit Electronically

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Prepare/Submit Electronically

• Submit electronic report to FDA: 

– FDA Electronic Submissions Gateway (ESG) 

– Requires ESG Account 

• FDA emails acknowledgement immediately 

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2. Prepare Electronically and 

Email or Mail

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Prepare Electronically & Email/Mail

Prepare report using eSubmitter (as previous method)

Email 

• Save as .pdf 

• Email to 

RadHealthCustomerServi

ce@fda.hhs.gov

Mail 

• Transfer to Physical Media 

(e.g., CD, DVD, memory 

stick) 

• Mail to FDA for processing

Acknowledgement emailed within 30 calendar days

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3. Prepare Hard Copy 

and Mail

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• Prepare paper report: 

www.fda.gov/AboutFDA/ReportsManualsForms/Forms/RadiologicalHealth

Forms/default.htm

• Mail to FDA for processing 

• Acknowledgement sent, usually within 30 

calendar days

Prepare Hard Copy and Mail

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www.fda.gov/radiation-emitting-products/getting-radiation-emittingproduct-market-frequently-asked-questions/submitting-reports-andrequirements-maintaining-records-radiation

Reports and Requirements for 

Maintaining Records for Radiation

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FDA Acknowledgement Letter

• Acknowledgement that report was received 

• FDA will contact submitter if there are questions 

• Will be emailed when correct email provided 

• An assigned Accession Number 

– used as reference for follow-up

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Accession Numbers

• Document control number to track report 

• NOT an approval number (e.g., for premarket approval) 

• Indicates that FDA has received report 

• Manufacturer may market product in United States 

– after required report has been submitted AND 

– product is not an unapproved medical device

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Reminder

• Acknowledgement Letter 

– only indicates that FDA received report 

– does not indicate that FDA reviewed report 

• Accession Number 

– does not indicate that product is approved by FDA 

• Manufacturer self - certifies compliance with FDA 

requirements 

• Report is tool FDA uses to evaluate product safety

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Summary

1. FDA has an important role in regulating electronic products. 

2. A manufacturer has key roles before electronic products 

may enter the U.S. market. 

– This includes complying with applicable standards and sending 

reports to FDA. 

3. Electronic product requirements differ from device 

requirements. 

– Both sets of requirements may apply to your product. 

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Resources: Radiological Health

• Walk - Through 

www.fda.gov/RadiationEmittingProducts/ElectronicProductRadiationControlProgram/Get

tingaProducttoMarket/ucm202505.htm 

• Performance Standards 

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm

?CFRPartFrom=1000&CFRPartTo=1050

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Resources: Radiological Health

• Medical Device Requirements 

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cf

m?CFRPart=807

• Radiation - Emitting Products Website 

www.fda.gov/Radiation-EmittingProducts/default.htm

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Industry Education: 

Three Resources for You

1. CDRH Learn: Multi - Media Industry Education 

§ over 200 modules 

§ videos, audio recordings, power point presentations, software - based “how to” modules 

§ mobile - friendly: access CDRH Learn on your portable devices 

www.fda.gov/Training/CDRHLearn 

2. Device Advice: Text - Based Education 

§ comprehensive regulatory information on premarket and postmarket topics 

www.fda.gov/MedicalDevices/DeviceAdvice 

3. Division of Industry and Consumer Education (DICE) 

§ Contact DICE if you have a question 

§ Email: DICE@fda.hhs.gov 

§ Phone: 1(800) 638 - 2041 or (301) 796 - 7100 (Hours: 9 am - 12:30 pm; 1 pm - 4:30pm EST) 

§ Web: www.fda.gov/DICE

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