WORLD TRADE
ORGANIZATIONG/TBT/Notif.00/79
15 February 2000
(00-0578)
Committee on Technical Barriers to Trade
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 (5)
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):   Medical Devices
5. Title, number of pages and language(s) of the notified document:   Amendment of
Various Device Regulations to Reflect Current American Society for Testing and Materials
Citations;  Companion Document to Di rect Final Rule (3 pages, English)
6. Description of content:   The Administration is proposing to amend certain references in
various medical device regulations.  The amendments would update the references in those
regulations to various standards of the Ameri can Society for Testing and Materials (ASTM) to
reflect the current standards designations.
7. Objective and rationale, including the na ture of urgent problems where applicable:
Updating ASTM citations used in various device regulations.
8. Relevant documents:   65 FR 3627 and 3584, 24 January 2000; 21 CFR Part 801.   Will
appear in the Federal Register when adopted.
9. Proposed date of adoption:  To be determined
Proposed date of entry into force:
10. Final date for comments:   10 April 2000
11. Texts available from:  National enquiry point [ X] or address, e-mail and telefax
number of the other body:   The text is also available on the Internet at:
http://www.access.gpo.gov/nara/index.html