. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/USA/734 
21 August 2012  
 (12-4540) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6 
 
1. Notifying Member:  UNITED STATES  
If applicable, name of local governme nt involved (Article 3.2 and 7.2):     
2. Agency responsible:  Food and Drug Administration (F DA), Health and Human Services 
(HHS) (745) 
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 :    
3. Notified under Article 2.9.2 [ X ], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other:   
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable):  Medical devices 
(ICS 11.040) 
5. Title, number of pages and language(s) of the notified document:  Implementation of 
Device Registration and Listing Requirements Enacted in the Public Health Security and 
Bioterrorism Prepared ness and Response Act of 2002, th e Medical Device User Fee and 
Modernization Act of 2002, and Title II of the Food and Drug Administration Amendments 
Act of 2007 (18 pages, in English).     
6. Description of content:  The Food and Drug Administration (FDA) is amending its 
regulations to reflect recent statutory amendments to the device registration and listing 
provisions of the Federal Food, Drug, and Cosm etic Act (FD&C Act).  The Food and Drug 
Administration Amendments Act of 2007 (FDAAA), enacted on 27 September 2007, 
amended the FD&C Act by requiring domestic and foreign device esta blishments to begin 
submitting their registration and device listing information to FDA by electronic means rather 
than on paper forms, and also specified the tim eframes when establishments are required to 
submit such information.  In addition, this fi nal rule would facilitate FDA's collection of 
additional registration information from forei gn establishments as required by the Public 
Health Security and Bioterro rism Preparedness and Response Act of 2002 (Bioterrorism Act). 
The final rule will update certain provisions in the regulations to improve the quality of registration and listing informat ion available to FDA.  FDA relies on having complete and 
accurate registration and listi ng information in order to accomplish a number of important 
public health objectives. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human life.  G/TBT/N/USA/734 
Page 2  
 
   
8. Relevant documents:   77 Federal Register (FR) 45927,  2 August 2012; Title 21 Code of 
Federal Regulations (CFR) Part 807.  Will appear in the Fe deral Register when adopted.   
9. Proposed date of adoption:   
Proposed date of entry into force:    To be determined 
1 October 2012   
10. Final date for comments:   - 
11. Text available from:  National enquiry point [X], or address, telephone and fax 
numbers, e-mail and web-site addres ses, if available of the other body:    
Internet URLs: 
http://www.gpo.gov/fdsys/pkg/ FR-2012-08-02/html/2012-18764.htm  
http://www.gpo.gov/fdsys/pkg/FR-2012-08-02/pdf/2012-18764.pdf