| 通报号: G/TBT/N/USA/1200 |
ICS号: 11.040
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发布日期: 2016-09-28
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截至日期: 2016-09-28
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通报成员: 美国
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目标和理由: 保护人类安全和健康
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内容概述: 食品药品管理局（FDA）现将磁疗仪系统分到II类（特别管控）。适用于该类设备的特别管控在本法令中确定，将成为磁疗仪系统分类编纂语言的一部分。FDA现将此类设备归为II类（特别管控），以便为此类设备的安全和功效提供合理的保证。
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正文:
| 世界贸易组织 |
G/TBT/N/USA/1200
2016-09-28
16-5182
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| 技术性贸易壁垒 |
原文：英语
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通 报
以下通报根据TBT协定第10.6条分发
| 1. |
通报成员: 美国
如可能，列出涉及的地方政府名称 ( 3.2条和7.2 条)：
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| 2. |
负责机构：卫生及公共服务部(HHS)食品药品管理局(FDA) [1218]
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| 3. |
通报依据条款：
[ ] 2.9.2
[ ] 2.10.1
[ ] 5.6.2
[ ] 5.7.1
通报依据的条款其他： X
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| 4. |
覆盖的产品： 磁疗仪系统。医疗设备。 ICS: 11.040 HS:
HS编码：9018,9022 ICS编码：11.040
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| 5. |
通报标题： 医疗设备；一般和整形外科设备；磁疗仪系统分类。
语言：英语 页数：3 链接网址：
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| 6. |
内容简述： 食品药品管理局（FDA）现将磁疗仪系统分到II类（特别管控）。适用于该类设备的特别管控在本法令中确定，将成为磁疗仪系统分类编纂语言的一部分。FDA现将此类设备归为II类（特别管控），以便为此类设备的安全和功效提供合理的保证。
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| 7. |
目标与理由：保护人类健康安全。
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| 8. |
相关文件： 2016年9月21日联邦纪事（FR）第81卷第64761页；联邦法规法典（CFR）第21编第878部分。
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| 9. |
拟批准日期：2016/06/13
拟生效日期：2016/09/21
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| 10. |
意见反馈截止日期： 无
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| 11. |
文本可从以下机构得到：
[ ] 国家通报机构
[ ] 国家咨询点，或其他机构的联系地址、传真及电子邮件地址(如能提供):
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正文(英):
NOTIFICATION
The following notification is being circulated in accordance with Article 10.6
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1.
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Notifying Member: United States of America
If applicable, name of local government involved (Article 3.2 and 7.2):
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2.
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Agency responsible: Food and Drug Administration (FDA), Health and Human Services (HHS) [1218]
Name and address (including telephone and fax numbers, email and website addresses, if available) of agency or authority designated to handle comments regarding the notification shall be indicated if different from above:
Please submit comments to: USA WTO TBT Enquiry Point
Email: usatbtep@nist.gov
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3.
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Notified under Article 2.9.2 [ ], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], other: X
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4.
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Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): Magnetic surgical instrument systems. Medical equipment (ICS: 11.040)
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5.
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Title, number of pages and language(s) of the notified document: Medical Devices; General and Plastic Surgery Devices; Classification of the Magnetic Surgical Instrument System (3 pages, in English)
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6.
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Description of content: The Food and Drug Administration (FDA) is classifying the Magnetic Surgical Instrument System into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the magnetic surgical instrument system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
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7.
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Objective and rationale, including the nature of urgent problems where applicable: Protection of human health or safety
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8.
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Relevant documents: 81 Federal Register (FR) 64761, 21 September 2016; Title 21 Code of Federal Regulations (CFR) Part 878
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9.
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Proposed date of adoption: 13 June 2016
Proposed date of entry into force: 21 September 2016
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10.
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Final date for comments: None
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11.
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Texts available from: National enquiry point [ ] or address, telephone and fax numbers and email and website addresses, if available, of other body:
https://members.wto.org/crnattachments/2016/TBT/USA/16_4031_00_e.pdf
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