1.

Notifying Member: United States of America

If applicable, name of local government involved (Article 3.2 and 7.2):

2.

Agency responsible: Food and Drug Administration (FDA), Health and Human Services (HHS) [1219]

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

3.

Notified under Article 2.9.2 [ ], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], other: X

4.

Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): Strabismus detection device. Medical equipment (ICS: 11.040)

5.

Title, number of pages and language(s) of the notified document: Medical Devices; Ophthalmic Devices; Classification of Strabismus Detection Device (3 pages, in English)

6.

Description of content: The Food and Drug Administration (FDA) is classifying the strabismus detection device 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 strabismus detection device'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.

7.

Objective and rationale, including the nature of urgent problems where applicable: Protection of human health or safety

8.

Relevant documents: 81 Federal Register (FR) 65279, 22 September 2016; Title 21 Code of Federal Regulations (CFR) Part 886

9.

Proposed date of adoption: 8 June 2016

Proposed date of entry into force: 22 September 2016

10.

Final date for comments: –

11.

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_4030_00_e.pdf