   
  
G/TBT/N/USA/1466  
 
11 April 2019  
(19-2402) Page: 1/1 
Committee on Technical Barriers to Trade  Original: English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  UNITED STATES OF AME RICA  
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) [1492]  
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):  Auto 
titration device for oral appliances; Medical equipment (ICS 11.040)  
5. Title, number of pages and language(s) of the notified document:  Medical Devices; 
Dental Devices; Classification of the Auto Titration Device for Oral Appliances (3 page(s), 
in English)  
6. Description of content:  The Food and Drug Administration (FDA or we) is classifying 
the auto titration device for oral appliances 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 auto titration device for oral appliances' 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 p art by reducing regulatory burdens.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety; Cost saving and productivity 
enhancement  
8. Relevant documents:   
• 84 Federal Register (FR) 4998, 20 February 2019; Title  21 Code of Federal 
Regulations (CFR) Part 872.  
9. Proposed date of adoption:  23 August 2018  
Proposed date of entry into force:  20 February 2019  
10. Final date for comments:  None 
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/2019/TBT/USA/19_2122_00_e.pdf  
 