WORLD TRADE
ORGANIZATIONG/TBT/N/USA/29
8 January 2003
(03-0041)
Committee on Technical Barriers to Trade Original:  English
NOTIFICATION
The following notification is being circulated in accordance with Article 10.6.
1. Member to Agreement notifying:   UNITED STATES
If applicable, name of local government involved (Articles 3.2 and 7.2):           
2. Agency responsible:   Food and Drug Administration (29)          
Name and address (including telephone and fax numbers, e-mail and web-site
addresses, if available) of  agency or authority designated to handle comments
regarding the notification shall be indicated if different from above:           
3. Notified under Article 2.9.2 [ X], 2.10.1 [    ], 5.6.2 [    ], 5.7.1 [    ], other:           
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading.
ICS numbers may be provided in addition, where applicable):   Diagnostic X-Ray
Systems (ICS 11)
5. Title, number of pages and language(s) of the notified document:   Electronic Products;
Performance Standard for Diagnostic X-Ray Systems and Their Major Components
(39 pages, English)          
6. Description of content:   The Food and Drug Administrati on (FDA) is proposing to amend
the performance standard for diagnostic x-ray systems and their major components.  For
clarity and ease of understanding, FDA is republishing the complete contents of the affectedregulations.  This action is being taken under the Federal Food, Drug, and Cosmetic Act, as
amended by the Safe Medical Devices Act of 1990.
7. Objective and rationale, including the na ture of urgent problems where applicable:
To update the standard to account for changes in technology and use of radiographic and
fluoroscopic systems as well as to fully utilize the currently accepted metric system of units
in the standards.          
8. Relevant documents:   67 Federal Register (FR)76056, 10 December 2002; Title 21 Code
of Federal Regulations (CFR) Part 1020.  Will appear in the Federal Register when adopted.
9. Proposed date of adoption:
Proposed date of entry into force: }To be determined
10. Final date for comments:   9 April 2003
11. Texts available from:  National enquiry point [ X] or address, telephone and fax
numbers, e-mail and web-site addresses, if available of the other body:
http://www.access.gpo.gov/nara/index.html