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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) [1445]
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): Light based energy source device for topical application; 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 Light Based Energy Source Device for Topical
Application (3 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 light based energy source
device for topical application 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 light based energy source device for
topical application'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) 52968, 19 October 2018; Title 21 Code of Federal
Regulations (CFR) Part 878.
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9.
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Proposed
date of adoption: 18
October 2012
Proposed date of entry into force: 19 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_5915_00_e.pdf
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