WORLD TRADE
ORGANIZATIONG/TBT/Notif.99.289
18 June 1999
(99-2472)
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 (21)
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):   Female Condoms
5. Title, number of pages and language(s) of the notified document:   Obstetrical and
Gynaecological Devices;  Proposed Classification of Female Condoms (5 pages, English)
6. Description of content:   The Administration is proposing to classify the preamendments
female condom intended for contraceptive and prophylactic purposes.  Under this proposal,
the preamendments female condom would be classified into class III (premarket approval).
After considering public comments on this classification proposal, the Administration willpublish a final rule classifying this device.
7. Objective and rationale, including the na ture of urgent problems where applicable:
To establish regulatory controls that will provide reasonable assurance of the safety and
effectiveness of this device.
8. Relevant documents:   64 FR 31164, 10 June 1999;  21 CFR Part 884.  Will appear in the
Federal Register when adopted.
9. Proposed date of adoption:  The Administration proposes that any final rule that may be
issued based on this proposal become effective 30 days after its date of publication in the
Federal Register
Proposed date of entry into force:
10. Final date for comments:   8 September 1999
11. Texts available from:  National enquiry point [ X] or address, e-mail and telefax
number of the other body:   The text is available on the Internet at:
http://www.access.gpo.gov/nara/index.html