+--------------------------------------------------+-------------------+
| **[World Trade]{.smallcaps}**                    |                   |
|                                                  |                   |
| **[Organization]{.smallcaps}**                   |                   |
+--------------------------------------------------+-------------------+
|                                                  |                   |
+--------------------------------------------------+-------------------+
|                                                  | **                |
|                                                  | G/TBT/N/USA/175** |
|                                                  |                   |
|                                                  | 14 February 2006  |
+--------------------------------------------------+-------------------+
|                                                  | (06-0626)         |
+--------------------------------------------------+-------------------+
|                                                  |                   |
+--------------------------------------------------+-------------------+
| **Committee on Technical Barriers to Trade**     | Original: English |
+--------------------------------------------------+-------------------+

NOTIFICATION

The following notification is being circulated in accordance with
Article 10.6.

+----+---------------------------+---+---------------------------------+
| ** | **Member to Agreement     |   |                                 |
| 1. | notifying:** [UNITED      |   |                                 |
| ** | STATES]{.underline}       |   |                                 |
|    |                           |   |                                 |
|    | **If applicable, name of  |   |                                 |
|    | local government involved |   |                                 |
|    | (Articles 3.2 and 7.2):** |   |                                 |
|    |                           |   |                                 |
+----+---------------------------+---+---------------------------------+
| ** | **Agency responsible:**   |   |                                 |
| 2. | Food and Drug             |   |                                 |
| ** | Administration (FDA)      |   |                                 |
|    | (181)                     |   |                                 |
|    |                           |   |                                 |
|    | **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:**             |   |                                 |
+----+---------------------------+---+---------------------------------+
| ** | **Notified under Article  |   |                                 |
| 3. | 2.9.2 \[** X **\], 2.10.1 |   |                                 |
| ** | \[ **  **\], 5.6.2        |   |                                 |
|    | \[ **  **\], 5.7.1        |   |                                 |
|    | \[ **  **\], other:**     |   |                                 |
|    |                           |   |                                 |
+----+---------------------------+---+---------------------------------+
| ** | **Products covered (HS or |   |                                 |
| 4. | CCCN where applicable,    |   |                                 |
| ** | otherwise national tariff |   |                                 |
|    | heading.\                 |   |                                 |
|    | ICS numbers may be        |   |                                 |
|    | provided in addition,     |   |                                 |
|    | where applicable):**      |   |                                 |
|    |                           |   |                                 |
|    | Orthopedic Devices (HS    |   |                                 |
|    | Chapter: 9018; ICS:       |   |                                 |
|    | 11.040)                   |   |                                 |
+----+---------------------------+---+---------------------------------+
| ** | **Title, number of pages  |   |                                 |
| 5. | and language(s) of the    |   |                                 |
| ** | notified document:**      |   |                                 |
|    | Orthopedic Devices;       |   |                                 |
|    | Reclassification of the   |   |                                 |
|    | Intervertebral Body       |   |                                 |
|    | Fusion Device (4 pages,   |   |                                 |
|    | in English)               |   |                                 |
+----+---------------------------+---+---------------------------------+
| ** | **Description of          |   |                                 |
| 6. | content:** The Food and   |   |                                 |
| ** | Drug Administration (FDA) |   |                                 |
|    | is proposing to           |   |                                 |
|    | reclassify intervertebral |   |                                 |
|    | body fusion devices that  |   |                                 |
|    | contain bone grafting     |   |                                 |
|    | material, from class III  |   |                                 |
|    | (premarket approval) into |   |                                 |
|    | class II (special         |   |                                 |
|    | controls), and retain     |   |                                 |
|    | those that contain any    |   |                                 |
|    | therapeutic biologic      |   |                                 |
|    | (e.g., bone morphogenic   |   |                                 |
|    | protein) in class III.    |   |                                 |
|    | Elsewhere in this issue   |   |                                 |
|    | of the Federal            |   |                                 |
|    | Register,the FDA is       |   |                                 |
|    | announcing the            |   |                                 |
|    | availability of a draft   |   |                                 |
|    | guidance document that    |   |                                 |
|    | would serve as the        |   |                                 |
|    | special control if the    |   |                                 |
|    | FDA reclassifies this     |   |                                 |
|    | device. The agency is     |   |                                 |
|    | proposing this            |   |                                 |
|    | reclassification based on |   |                                 |
|    | the recommendation of the |   |                                 |
|    | Orthopaedic and           |   |                                 |
|    | Rehabilitation Devices    |   |                                 |
|    | Panel (the Panel).        |   |                                 |
+----+---------------------------+---+---------------------------------+
| ** | **Objective and           |   |                                 |
| 7. | rationale, including the  |   |                                 |
| ** | nature of urgent problems |   |                                 |
|    | where applicable:**       |   |                                 |
|    | Protection of human       |   |                                 |
|    | health                    |   |                                 |
+----+---------------------------+---+---------------------------------+
| ** | **Relevant documents:**   |   |                                 |
| 8. | 71 Federal Register (FR)  |   |                                 |
| ** | 6710 9 February 2006;     |   |                                 |
|    | Title 21 Code of Federal  |   |                                 |
|    | Regulations (CFR) Part    |   |                                 |
|    | 888. Will appear in the   |   |                                 |
|    | Federal Register when     |   |                                 |
|    | adopted.                  |   |                                 |
+----+---------------------------+---+---------------------------------+
| ** | **Proposed date of        |   | To be determined                |
| 9. | adoption:**               |   |                                 |
| ** |                           |   |                                 |
|    | **Proposed date of entry  |   |                                 |
|    | into force:**             |   |                                 |
+----+---------------------------+---+---------------------------------+
| *  | **Final date for          |   |                                 |
| *1 | comments:** 10 May 2006   |   |                                 |
| 0. |                           |   |                                 |
| ** |                           |   |                                 |
+----+---------------------------+---+---------------------------------+
| *  | **Texts available from:   |   |                                 |
| *1 | National enquiry point    |   |                                 |
| 1. | \[** X **\] or address,   |   |                                 |
| ** | telephone and fax         |   |                                 |
|    | numbers, e-mail and       |   |                                 |
|    | web-site addresses, if    |   |                                 |
|    | available of the other    |   |                                 |
|    | body:**                   |   |                                 |
|    |                           |   |                                 |
|    | Full Texts are Now        |   |                                 |
|    | Available on the Internet |   |                                 |
|    | at URLs:                  |   |                                 |
|    |                           |   |                                 |
|    | <http://a257.g.akama      |   |                                 |
|    | itech.net/7/257/2422/01ja |   |                                 |
|    | n20061800/edocket.access. |   |                                 |
|    | gpo.gov/2006/E6-1736.htm> |   |                                 |
|    |                           |   |                                 |
|    | <http://a257.g.akamaitec  |   |                                 |
|    | h.net/7/257/2422/01jan200 |   |                                 |
|    | 61800/edocket.access.gpo. |   |                                 |
|    | gov/2006/pdf/E6-1736.pdf> |   |                                 |
+----+---------------------------+---+---------------------------------+