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) [1443]
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): External upper limb tremor stimulator; 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; Neurological Devices; Classification of the
External Upper Limb Tremor Stimulator (2 page(s), in English)
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6.
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Description
of content: The Food and Drug
Administration (FDA or we) is classifying the external upper limb tremor
stimulator into class II (special controls). The special controls that apply
to the device type are identified in this order and will be part of the
codified language for the external upper limb tremor stimulator's
classification. We are taking this action because we have determined that
classifying the device into class II (special controls) will provide a
reasonable assurance of safety and effectiveness of the device. We believe
this action will also enhance patients' access to beneficial innovative
devices, in part by reducing regulatory burdens.
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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:
·
83 Federal
Register (FR) 52315, 17 October 2018; Title 21 Code of Federal
Regulations (CFR) Part 882.
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9.
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Proposed
date of adoption: 26
April 2018
Proposed date of entry into force: 17 October 2018
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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/2018/TBT/USA/18_5913_00_e.pdf
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