G/TBT/N/USA/1647  
22 September 2020  
(20-6385) Page: 1/2 
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 AMERICA   
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) [1675]  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the not ification 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):  
Cytomegalovirus (CMV) deoxyribonucleic acid (DNA) quantitative assay devices intended 
for transplant patient management; Medical equipment (ICS 11.040), Laboratory 
medicine (ICS 11.100)  
5. Title, number of pages and language(s) of the notified document:  Microbiology 
Devices; Reclassification of Cytomegalovirus Deoxyribonucleic Acid Quantitative Assay 
Devices Intended for Transplant Patient Management, To Be Renamed Quantitative 
Cytomegalovirus Nucleic Acid Tests for Transplant Patient Management (8 page(s ), in 
English)  
6. Description of content:  Proposed amendment; proposed order; request for comments 
- 
The Food and Drug Administration (FDA or the Agency) is proposing to reclassify 
cytomegalovirus (CMV) deoxyribonucleic acid (DNA) quantitative assay devic es intended 
for transplant patient management, a postamendments class III device (product code 
PAB) into class II (general controls and special controls), subject to premarket 
notification. FDA is also proposing a new device classification regulation with the name 
"quantitative cytomegalovirus (CMV) nucleic acid tests for transplant patient 
management" to identify these devices along with the special controls that the Agency 
believes are necessary to provide a reasonable assurance of safety and effectivenes s for 
the device. FDA is proposing this reclassification on its own initiative. If finalized, this 
order will reclassify these types of devices from class III (general controls and premarket 
approval) to class II (general controls and special controls) and  reduce the regulatory 
burdens associated with these devices as manufacturers of these types of devices will no 
longer be required to submit a premarket approval application (PMA), but can instead 
submit a premarket notification (510(k)) and obtain clearan ce, before marketing their 
device.  G/TBT/N/USA/1647  
 
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  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:   
85 Federal Register (FR) 58300, 18 September 2020; Title  21 Code of Federal 
Regulations (CFR) Part 866:  
https://www.govinfo.gov/content/pkg/FR -2020-09-18/html/2020 -20716.htm  
https://www.govinfo.gov/content/pkg/FR -2020-09-18/pdf/2020 -20716.pdf  
This proposed amendment; proposed order; request for comments is identified by Docket 
Number FDA -2016-N-2880. The Docket Folder is available on Regulations.gov  at 
https://www.regulations.gov/docket?D=FDA -2016-N-2880 and provides access to 
primary documents as well as comments received. Documents are also accessible from 
Regulations.gov  by searching the Docket Number.  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  17 November 2020  
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/cr nattachments/2020/TBT/USA/20_5639_00_e.pdf