. /.  WORLD TRADE  
ORGANIZATION  G/TBT/N/USA/101 
17 March 2005 
 
 (05-1102) 
Committee on Technical Barriers to Trade Original: English 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:   UNITED STATES
 
If applicable, name of local government involved (Articles 3.2 and 7.2):         
2. Agency responsible:   Food and Drug Administration  (106) 
Name and address (including telephone and fax numbers, e-mail and web-site 
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 (HS 
Chapter 3002;  ICS 11) 
5. Title, number of pages and language(s) of the notified document:   Medical Devices; 
Hematology and Pathology Devices; Reclassification from Class III to Class II of 
Automated Blood Cell Separator Device Operati ng by Centrifugal Separation Principle  (7 
pages, in English) 
6. Description of content:   The Food and Drug Administration (FDA) is proposing to 
reclassify from class III to cl ass II (special controls) the automated blood cell separator 
device operating on a centrifugal separation princi ple and intended for the routine collection 
of blood and blood components. This proposed ru le would also modify the special control 
for the device with the same intended use but operating on a filtration separation principle. 
The reclassification is being proposed on F DA's own initiative under procedures set forth in 
FDA regulations and based on information pr ovided to FDA. This action is being taken 
under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical 
Device Amendments of 1976 (the 1976 amen dments), the Safe Medical Devices Act of 
1990 (the SMDA), and the Food and Drug Admi nistration Modernization Act of 1997 
(FDAMA). The agency proposes this reclassificati on because special controls, in addition to 
general controls, are capable of providing reasonable assurance of the safety and effectiveness of the device. Elsewhere in th is issue of the Federal Register, FDA is 
publishing a notice of availability of a draft guidance document entitled "Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by 
Centrifugal or Filtration Separation Principle'', which will serve as the special control if this 
proposal becomes final. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health G/TBT/N/USA/101 
Page 2  
 
8. Relevant documents:   70 Federal Register (FR) 11887 10 March 2005; Title 21 Code of 
Federal Regulations (CFR) Part 864.  Will app ear 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:   8 June 2005 
11. Texts available from:  National enquiry point [  X ] or address, telephone and fax 
numbers, e-mail and web-site addresses, if available of the other body:   
Full Text of this Notification is Now Available on the Internet at URLs: 
http://a257.g.akamaitech.net/7/257/24 22/01jan20051800/edocket.access.gpo.gov/2005/05-
4758.htm  
http://a257.g.akamaitech.net/7/257/24 22/01jan20051800/edocket.access.gpo.gov/2005/pdf/
05-4758.pdf