. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/USA/720 
17 July 2012  
 (12-3880) 
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) (738) 
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 device  and device 
packages identification (ICS 11.040) 
5. Title, number of pages and language(s) of the notified document:  Unique Device 
Identification System (44 pages, in English)     
6. Description of content:  The Food and Drug Administration (F DA) is proposing to establish 
a unique device identification system to impl ement the requirement added to the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) by section 226 of the Food and Drug 
Administration Amendments Act of 2007 (F DAAA), Section 226 of  FDAAA amended the 
FD&C Act to add new section 519(f), which directs FDA to promulgate regulations 
establishing a unique device identification system  for medical devices. The system established 
by this rule would require the label of medi cal devices and device packages to include a 
unique device identifier (UDI), except where the rule provides for alternative placement of the 
UDI or provides an exception for a particular device or type of  device such as devices sold 
over-the-counter and low risk de vices. Each UDI would have to be provided in a plain-text 
version and in a form that uses automatic iden tification and data captu re (AIDC) technology. 
The UDI would also be required to be direc tly marked on the device itself for certain 
categories of devices for which the labelling requirement may not  be sufficient, for example, 
those that remain in use for an extended period of  time and devices that are likely to become 
separated from their labelling. The rule would require the submission of information concerning each device to a database that FDA intends to ma ke public, to ensure that the UDI 
can be used to adequately identify the device through its distribution and use. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human life.  G/TBT/N/USA/720 
Page 2  
 
  8. Relevant documents:   77 Federal Register (FR) 39953, 6 July 2012; Title 21 Code of Federal 
Regulations (CFR) Parts 16, 801, 803, 806, 810,  814, 820, 821, 822, and 830. Will appear in 
the Federal Register when adopted.   
9. Proposed date of adoption:   
Proposed date of entry into force:   } To be determined 
10. Final date for comments:  7 November 2012 
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-2012-07-10/html/2012-16621.htm  
http://www.gpo.gov/fdsys/pkg/FR-2012-07-10/pdf/2012-16621.pdf