# Presentation: 487024

## 	  Consumer Electronics & the FDA / CDRH Radiological Health Program

**Virginia Williams**
**Director of Engineering**
**Technology and Standards**

- October 31, 2005
- FDA / CDRH Stakeholder Meeting

## Overview

**CEA and the Consumer Electronics Industry**
**CE Industry Issues in Radiological Health **
**	****	****(monitoring, standards, and education) **
**CEA and CDRH – working together**
**Proposed next steps **

## CEA

**CEA is a full service trade association.**
- Mission: To Grow the CE Industry
- Standards, Government Policy, Research, Education, International CES ...
**~ 2,000 members in all aspects of the CE industry**
- Manufacturers, Distributors, Retailers, Installers, Consultants, Broadcasters, Other Services ...
- Chip Makers, Software, Hardware, Devices, Accessories ...
- Audio, Video, Computers, Cellphones, Gaming, ...
***CE industry > $120 billion in annual sales.***

## Technology and Standards

**R1  Product Safety**
- R3  Audio
- R4  Video
- R5  Antennas

- R6  Mobile Products
- R7  Home Networking
- R8  Cable Compatibility
- R9  Product ID

- _[http://www.ce.org/](http://www.ce.org/STANDARDS/)__[STANDARDS](http://www.ce.org/STANDARDS/)__[/](http://www.ce.org/STANDARDS/)_
- _[http://www.ce.org/](http://www.ce.org/SAFETY)__[SAFETY](http://www.ce.org/SAFETY)_

## Technology and Standards

**R1 Product Safety**
- Chair:
**  ****Ted Marks, JVC**
**R1wg6 Radiation Compliance**
- Chair:
**  ****Wayne Myrick, Sharp**

- Other industry members at workshop:
- Toshiba
- Sony
- Panasonic
- LGE
- Cannon

## R1  Product Safety

## R1  Product Safety

## R1  Product Safety

**X-Radiation From CRT Displays**
- A Tutorial and Compliance Guide
- Introduction
- History of Radiation Control for Health and Safety
- X-Radiation Generation in a Video Product
- X-Radiation Characteristics of Cathode Ray Tubes
- X-Radiation Characteristics in Chassis Design
- Measurement Equipment and Set-up
- Sample Testing
- Certification Testing
- Reporting and Record Keeping

## R1  Product Safety

- Support for international standards:
- IEC TC100, TC108, TC77, TC76, CISPR-I
- hazard-based approach
- full system evaluation (including product use)
- Support for NTRL certification (e.g. UL)

## CE Industry Perspective

- CE industry supports progressive changes
- regulatory process and enforcement
- increased automation and streamlining
- Products have demonstrated high level of safety
- only 1/3 of CDRH products non-medical
- low risk radiation products
- voluntary compliance ~100%
- less need for reporting & surveillance

## CE Industry Issues- Monitoring - 

- _General Issues_
- Implement Reduced  Reporting
- minimal Annual Report
- no Product Report
- Revise 2877 customs form

## CE Industry Issues- Monitoring -

- _Amend Annual Product Reporting Format_
- Declaration of Responsible Party’s contact name, telephone number and address, which must be located within U.S.  This may include declared primary responsible party, contact person, importer and/or agent.
- Include master list of all authorized manufacturer’s names and their county of origin, or another method to identify the contact person for a specific product.

## CE Industry Issues- Monitoring -

- _Relax Reporting Rules for Class I _
- 	_Laser, Television, and Microwave Oven* products_
- Elimination or reduction of Initial (Product) and Supplemental reporting rules for low radiation risk products - such as Class I laser, television, and microwave oven products.
- Recognition of certification marking in lieu of present reporting requirements.
- Traceability to responsible party still intact
- *  Microwave ovens are covered by AHAM.
- 	AHAM has reviewed and concurs with these recommendations.

## CE Industry Issues- Monitoring -

- _Revise Form FDA 2877 _
- Change to reflect “Responsible Party of Record” instead of “Name of Manufacturer of Record” to avoid discrepancies in interpretation (e.g. Box B1 v top portion)
- Amend instructions to better explain and interpret the declarations
- Change to allow import declaration without reference to reports for Class 1 laser, television, and microwave oven products

## CE Industry Issues- Standards -

- _General:_
- 	 _Harmonize the CFR with International Standards_
- How to reference the content – point to or copy text
- Timely synchronization of changes – revisions to standards
- Recognition of compliance marking – one mark and one test
- _Example:  Laser Notice 50_
- 21 CFR 1040 is only partially harmonized with the international standard (per deviations in Laser Notice 50)
- Different marks acceptable (Laser Notice 50 or 21 CFR 1040), neither are per the international standard

## CE Industry Issues- Education -

- No issues
- Warnings in product literature are adequate and effective
- CEA and manufacturers can help with general consumer awareness

## CEA and CDRH – working together

- Promote public awareness
****** **** **Print campaigns, CES presence
- Early indicators & new technologies
-   Suggest research topics
- Continuous improvement
-   Continue dialogue and feedback, especially on standards harmonization

## CEA and CDRH – working together

- Next steps – elaborate on details in workshop
- Time frame – make a commitment to implementation dates

## www.CE.org

**www.CE.org**

- Thank You
- _[vwilliams@ce.org](mailto:vwilliams@ce.org)__ _

## International CES

_**January 5-8, 2006 in Las Vegas**_
**	**The International Consumer Electronics Show (CES) is the world's largest annual tradeshow for consumer technology and America's largest annual tradeshow of any kind.
_**TechZones and Conference Program**_
- 	Highlighting new technologies, CEA initiatives, industry issues, and partners from industry and government
_**Green Day**_
**	****R**esponsible and safe handling over the full product life cycle

## Market Research

_**Consumer Research**_** **
**	**Since 1994, CEA has conducted nearly 200 custom research studies focusing on consumers and CE products. Each year, CEA commissions more than 20 new consumer studies.
_**MARA - Market Activity Report and Analysis**_
- 	500 reports annually, 100+ companies participate_** **_
_**Research Library**_
**	**Historical Sales (fast facts), Forecasts, Daily Alert, Readers Guide (web search)
_**E-Brain **_
- 	Customized, commissioned research

## Hot CE Technologies5 technologies to watch in 2005 

- Media **Servers**
- Portable **Entertainment**
- Hybrid **White Goods**
- Innovative **Gaming**
**Telematics**

## Future of CE Technologyfrom the 5  technologies to watch 

- Biometrics
- Nanotechnology
- Robotics
- Wearable computers
- Flexible displays
- Software radios

## Education

_**CEKnowHow**_
- Retail training programs
- Information “pass-through” to consumers
_**Training Markets**_** **
- DTV
- Audio
- Mobile
- Wireless
- Digital Imaging
- Home Networking

- _[http://www.ceknowhow.com](http://www.ceknowhow.com/)_

## CEA Product Marks