. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/USA/683 
29 February 2012  
 (12-1155) 
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:  Department of Health and Huma n Services (HHS), Food and Drug 
Administration (FDA)  (700) 
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):  Gastroenterology-urology 
devices (ICS: 11.040) 
5. Title, number of pages and language(s) of the notified document:  Gastroenterology-
Urology Devices; Reclassification of Sorben t Hemoperfusion Devices for the Treatment of 
Poisoning and Drug Overdose; Effective Date of Requirement for Pr emarket Approval for 
Sorbent Hemoperfusion Devices To Treat He patic Coma and Metabolic Disturbances 
(8 pages, in English). 
6. Description of content:  The Food and Drug Administration (FDA) is proposing to reclassify 
the sorbent hemoperfusion system, a preamendme nts class III device, into class II (special 
controls) for the treatment of poisoning and drug overdose, and to re quire the filing of a 
premarket approval application (PMA) or a notice of completion of a product development 
protocol (PDP) for the treatment of hepati c coma and metabolic disturbances. FDA is 
identifying the proposed special controls that the Agency believes will reasonably ensure the safety and effectiveness of the device for th e treatment of poisoning and drug overdose. The 
Agency is also summarizing its  proposed findings regarding the degree of risk of illness or 
injury designed to be eliminated or reduced by requiring the devices to meet the statute's 
approval requirements and the benefits to the public from the use of the devices. In addition, 
FDA is announcing the opportunity for interested  persons to request that the Agency change 
the classification of any of the devices menti oned in this document based on new information. 
This action implements certain statutory requirements.  
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of the human life.  
8. Relevant documents:   77 Federal Register (FR), 17 Fe bruary 2012; 21 CFR Part 876.  Will 
appear in the Federal Register when adopted.   G/TBT/N/USA/683 
Page 2  
 
  9. Proposed date of adoption:   
Proposed date of entry into force:    To be determined 
10. Final date for comments:  17 May 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-2012-02-17/html/2012-3810.htm  
http://www.gpo.gov/fdsys/pkg/FR-2012-02-17/pdf/2012-3810.pdf