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) [1450]
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): Active implantable bone conduction hearing system; 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; Ear, Nose, and Throat Devices; Classification of
the Active Implantable Bone Conduction Hearing System (4 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 active implantable bone
conduction hearing system 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 active implantable bone conduction
hearing system'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) 54007, 26 October 2018; Title 21 Code of Federal
Regulations (CFR) Part 874.
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9.
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Proposed
date of adoption: 20
July 2018
Proposed date of entry into force: 26 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_5920_00_e.pdf
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