   
  
G/TBT/N/USA/1608/Add.1  
 
23 November  2021 
(21-8830) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
NOTIFICATION  
Addendum  
The following communication , dated  23 November 2021 , is being circulated at the request of the 
delegation of the United States of America . 
 
_______________  
 
 
Title: Microbiology Devices; Reclassification of Certain Hepatitis C Virus Antibody Assays Devices, 
To Be Renamed Hepatitis C Virus Antibody Tests  
 
Reason for Addendum:  
[  ] Comment period changed - date:   
[X] Notified measure adopted - date: 22 December 2021  
[X] Notified measure published - date: 22 November 2021  
[  ] Notified measure enters into force - date:  
[X] Text of final measure available from1:  
https://www.govinfo.gov /content/pkg/FR -2021-11-22/html/2021 -25374.htm  
https://www.govinfo.gov/content/pkg/FR -2021-11-22/pdf/2021 -25374.pdf  
https://members.wto.org/crnattachments/2021/TBT/USA/final_measure/21_7291_00_
e.pdf 
[  ] Notified measure withdrawn or revoked - date:  
Relevant symbol if measure re -notified:   
[  ] Content or scope of notified measure changed  and text available from1:  
New deadline for comments (if applicable):   
[  ] Interpretive guidance issued and text available from1:  
[  ] Other:  
 
Description:    
TITLE: Microbiology Devices; Reclassification of Certain Hepatitis C Virus Antibody Assay Devices, 
Renamed to Hepatitis C Virus Antibody Tests  
AGENCY: Food and Drug Administration, HHS.  
ACTION: Final amendment; final order.  
SUMMARY: The Food and Drug Administration (FDA or the Agency) is issuing a final order to 
reclassify certain hepatitis C virus (HCV) antibody assay devices intended for the qualitative 
detection of HCV, postamendments class III devices (product code MZO) into class II (general 
controls and special controls), subject to premarket notification. FDA is renaming and codifying these 
 
1 This information can be provided by including a website address, a pdf attachment, or other 
information on where the text of the final /modified  measure and/or interpretive guidance can be obtained.  G/TBT/N/USA/1608/Add.1  
 
- 2 - 
 
  devices under the classification regulation named "hepatitis C virus (HCV) antibody tests." FDA is 
also identifying the special controls that the Agency believes are necessary to provide a reasonable 
assurance of safety and effectiveness of these devices.  
DATES: This order is effective 22 December 2021.  
This Final amendment; final order and the Proposed amendment; proposed order; request for 
comments notified in G/TBT/N/USA/1608  are identified by Docke t No. FDA -2020-N-1082.   The 
docket folder is available on Regulations.gov  and provides access to primary and supporting 
documents as well as comment received at https://www.regulations.gov/docket/FDA -2020-N-
1082.  Documents are also accessible from Regulations.gov  by searching the Docket Number.  
__________  
 
 