Electronic Product Certification and 

Quality Testing Programs

Lowell Howard, PhD

Electrical Engineer

Center for Devices and Radiological Health (CDRH)

U.S. Food and Drug Administration
Learning Objectives

1. Summarize background information

2. Explain what Electronic Product Certification 

represents

3. Define manufacturer’s certification responsibility

4. Define a quality testing program

5. Identify consequences of a poor quality testing 

program

2
Background

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Radiation-Emitting Electronic Products 

• Homes: Microwave ovens, DVD/Blu-ray players, 

cell phones and wireless devices

• Airports: Body and baggage security screening

• Entertainment Venues: Laser Light Shows

• Hospitals: X-ray machines, surgical lasers, 

ultrasound, MRI, and radiation therapy

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• 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)

FDA Standards Apply to 

a Range of Products

5
How Does FDA Regulate

Radiation-Emitting Electronic Products?

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

– Electronic Product Radiation Control (EPRC) provisions

– Sections 531 – 542, Certification is referenced in Section 534

• Code of Federal Regulations (CFR)

– Title 21, Parts 1000 – 1050, 

Certification specified in 21 CFR 1010.2

Note: Applies to Manufacturers only

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Certification

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What is Certification?

Certification is made by 

the manufacturer, based 

upon testing, that their 

product complies with 

applicable standards

21 CFR 1010.2

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Certification

Quality Testing 

Program

Performance Standards
Electronic Product Certification

• Only manufacturers of electronic products with 

mandatory FDA performance standards certify

• Self-certification does NOT indicate FDA clearance or 

approval

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Electronic Product Certification

• When is it done?

• Prior to entry into U.S. Commerce or import

• How is Certification made? 

• In form of label or tag, permanently attached to product

• Certification statement must be in English language

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Certification Differs from European 

Union Declaration of Conformance

• U.S. Agencies may each have different requirements, 

instead of one global declaration of conformance

• Documents are required prior to or when product is 

introduced into U.S. Commerce

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Manufacturer’s Certification 

Responsibility

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Manufacturer’s Certification 

Responsibility: Total Product Life Cycle

• Awareness of requirement to certify

• Product design for compliance to applicable standards

• Manufacture and test of finished, compliant product

• Product reporting to FDA under 21 CFR 1002

• “Sustaining Engineering” under 21 CFR 1002.30

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Example: Certification Statements

• Complies with 21 CFR, Subchapter J (Radiological Health)

• Product complies with applicable FDA standards under the 

Federal Food, Drug, and Cosmetic Act

• Product complies with applicable Federal standards under 

the Electronic Product Radiation Control provisions

Note: Laser Notice 53 provides certain alternate labeling 

situations without prior approval

14
Variations of Certification Statement

• FDA’s Electronic Product Radiation Control Program 

may permit certification that represents conformance 

to other standards

Example: Laser Notice 50 and 56 permit IEC 60825-1

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Quality Testing Program (QTP)

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Purpose

• Assures consistency, repeatability, quality in product 

line manufactured over time

• Assures adequacy of employee training and 

performance

• Assures defects, noncompliances, and problems are 

caught prior to product shipment

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Purpose

• To detect instances of non-compliance by design

– report according to 21 CFR 1003.10

• Required by 21 CFR 1010.2 (c)

– further explained in 21 CFR 1002.30

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What Constitutes a QTP?

• Records of tests and measurements, 

21 CFR 1002.30

• Sales and distribution records that facilitate 

corrective actions, if they become necessary

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Manufacturers’ Records

21 CFR 1002.30

(a)(1) Description of the quality control procedures

(a)(2) Records of the results of tests for electronic 

product radiation safety, including:

• the control of unnecessary, secondary or leakage electronic 

product radiation;

• the methods, devices, and procedures used in such tests; and

• the basis for selecting such methods, devices, and procedures.

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Manufacturers’ Records

21 CFR 1002.30

(a)(3) For those products displaying aging effects, records 

of the results of tests for: 

• durability and stability of the product

• the basis for selecting these tests

21
Manufacturers’ Records

21 CFR 1002.30

(a)(4) Copies of all written communications:

• radiation safety

• complaints

• investigations

• instructions

• explanations 

22
Manufacturers’ Records

21 CFR 1002.30

(a)(5) Data on production and sales volume levels, if 

available 

• Data provide insights during product corrective 

actions

• Data can be used to narrow the scope to include 

only the defective production

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Product Compliance

Radiation-emitting electronic components or finished 

products are inspected as part of good manufacturing 

practices:

Example: Validate that a vendor’s radiation-emitting 

electronic components perform to design specifications

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Production Tests

Characterize product functions during assembly and 

integration process:

• Test the function of safety interlock when actuated

• Test at end of assembly for prescribed radiation 

parameters

• Test to check labeling for U.S. compliance

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Common Issues

• Failure to identify nonperforming incoming components

• Sampling not statistically valid and if not 100% inspected 

• Statistically valid sample not documented

• Manufacturer needs to document that statistical sampling 

is adequate to assure compliance of finished products

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Consequences of a Poor

Quality Testing Program

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Consequences of a Poor QTP

• Non-compliance by design

• Non-compliance by product-aging effects

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Consequences of a Poor QTP

• Violation of Section 538.(a)(5)(B) of the FD&C Act

NOTE: Ultimately the manufacturer is responsible for 

their product's compliance

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Consequences of a Poor QTP

Inaccurate, incomplete, or fraudulent information in product 

reports or import documents can lead to:

• Increased surveillance of accession number assigned to product report

• Mandatory corrective actions of defects or non-compliances

• Import delays, product sampling for testing, or being placed on an FDA 

Import Alert

• Program disapproval

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Notifications

• Notification of defects or noncompliance, 21 CFR 

CFR 1003 and Plan of Action, 21 CFR 1004 

• Notify FDA of your defect and propose a plan to 

repair, replace, or refund the product at no cost to 

the purchaser

• FDA may approve your plans with added conditions

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Import Alerts

• Import alerts inform FDA field staff and public

– that FDA has enough evidence to allow for detention without physical 

examination of products

• Product appears to be in violation of U.S. laws and FDA 

regulations

• Import Alert list is public and searchable by potential customers 

and competitors

• Detention can result in import delays, storage fees, seizures and 

refusals

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Program Disapproval

Program disapproval under 21 CFR 1010.2 (c)

• Testing program does not assure adequacy of safeguards 

against hazardous electronic product radiation 

• Testing program does not assure that electronic products 

comply with standards prescribed under this subchapter

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Summary

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

2. Before electronic products enter the U.S. market, a 

manufacturer must:

• Comply with applicable standards

• Establish an adequate quality testing program

• Certify the product, and report it to FDA, if required by 21 CFR 

1002.1

3. Entry to commerce of noncompliant or defective products can 

have consequences 34
Resources/Reference

• Radiation-Emitting Electronic Product Regulations

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

?CFRPartFrom=1000&CFRPartTo=1050

• Medical Device Requirements

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

m?CFRPart=807

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Providing Industry Education

1. CDRH Learn – Multi-Media Industry Education

 over 100 modules - videos, audio recordings, PowerPoint presentations, 

software-based “how to” modules

 accessible on your portable devices: www.fda.gov/CDRHLearn

2. Device Advice – Text-Based Education

 comprehensive regulatory information on premarket and postmarket topics: 

www.fda.gov/DeviceAdvice

3. Division of Industry and Consumer Education (DICE)

 Email: DICE@fda.hhs.gov

 Phone: 1-800-638-2041 or (301) 796-7100 (Live Agents 9 am – 12:30 pm; 1 – 4: 

30 pm ET)

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Your Call to Action

• Understand the requirements for a good quality 

testing program

• Manage your products to ensure they remain 

compliant and address detected problems 

effectively 

• Document the use of valid statistical sampling

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