G/TBT/N/USA/1605/Add.1  
 
17 May 2022  
(22-3810) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
 
NOTIFICATION  
Addendum  
The following communication , dated  17 May 2022, is being circulated at the request of the delegation 
of the United States of America . 
 
_______________  
 
 
Title:  Microbiology Devices; Reclassification of Human Immunodeficiency Virus Serological 
Diagnostic and Supplemental Tests and Human Immunodeficiency Virus Nucleic Acid Diagnostic and 
Supplemental Tests  
 
Reason for Addendum:  
[ ] Comment period changed - date:   
[ ] Notified measure adopted - date:  
[X] Notified measure published - date: 16 May 2022  
[X] Notified measure enters into force - date: 15 June 2022  
[X] Text of final measure available from1:  
https://www.govinfo.gov/content/pkg/FR -2022-05-16/html/2022 -10461.htm  
https://www.govinfo.gov/content/pkg/FR -2022-05-16/pdf/2 022-10461.pdf  
https://members.wto.org/crnattachments/2022/TBT/USA/final_measure/22_3449_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[ ] Notified measure withdrawn or revoked - date:  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 Human Immunodeficiency Virus 
Serological Diagnostic and Supplemental Tests and Human Immunodeficiency Virus Nucleic Acid 
Diagnostic and Supplemental Tests  
AGENCY: Food and Drug Administration, HHS  
ACTION: Final amendment; final order  
SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is issuing a final order to 
reclassify c ertain human immunodeficiency virus (HIV) serological diagnostic and supplemental tests 
and HIV nucleic acid (NAT) diagnostic and supplemental tests, postamendments class III devices 
 
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/1605/Add.1  
 
- 2 - 
 
  with the product code MZF, into class II (special controls), subject to p remarket notification. Through 
this final order, FDA is also adding two new device classification regulations and identifying special 
controls that the Agency believes are necessary to provide a reasonable assurance of safety and 
effectiveness for these de vice types. This final order will reduce the regulatory burdens associated 
with these device types, as manufacturers will no longer be required to submit a premarket approval 
application (PMA) but can instead submit a premarket notification (510(k)) and re ceive clearance 
before marketing their device.  
This order is effective 15 June 2022.  
This final amendment; final order and the proposed amendment; proposed order notified as 
G/TBT/N/USA/1605  are identified by Docket Number FDA -2019-N-5192. The Docket Folder is 
available on Regulations.gov at https://www.regulations.gov/docket/FDA -2019-N-5192/docume nt 
and provides access to primary and supporting documents as well as comments received. Documents 
are also accessible from Regulations.gov  by searching the Docket Number.  
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