G/TBT/N/USA/1605  
20 April 2020  
(20-3090) 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 AME RICA  
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) [1635]  
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):  
HIV serological diagnostic and supplemental tests and HIV nucleic acid (NAT) diagnostic 
and supplemental tests; Diagnostic equipment (ICS 11.040.55), Laboratory medicine 
(ICS 11.100)  
5. Title, number of pages and language(s) of the notified document:  Microbiology 
Devices; Reclassification of Human Immunodeficiency Virus Serological Diagnostic an d 
Supplemental Tests and Human Immunodeficiency Virus Nucleic Acid Diagnostic and 
Supplemental Tests (9 page(s), in English)  
6. Description of content:  Proposed amendment; proposed order - The Food and Drug 
Administration (FDA or the Agency) is proposing to reclassify certain human 
immunodeficiency virus (HIV) serological diagnostic and supplemental tests and HIV 
nucleic acid (NAT) diagnostic and supplemental tests, postamendments class III devices 
with the product code MZF, into class II (special controls ), subject to premarket 
notification. FDA is also proposing new device classification regulations along with special 
controls that the Agency believes are necessary to provide a reasonable assurance of 
safety and effectiveness for these devices. FDA is pro posing this reclassification on its own 
initiative. If finalized, this order will reclassify these types of devices from class III 
(premarket approval) to class II (special controls) and reduce the regulatory burdens 
associated with these devices, as 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 receive clearance before marketing their device.  
7. Objective and rationale, including the nature of  urgent problems where 
applicable:  Protection of human health or safety  G/TBT/N/USA/1605  
 
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  8. Relevant documents:   
• 85 Federal Register (FR) 10110, 21 February 2020; Title  21 Code of Federal 
Regulations (CFR) Part 866:  
https://www.govinfo.gov/content/pkg/FR -2020-02-21/html/2020 -03515.htm  
https://www.govinfo.gov/content/pkg/FR -2020-02-21/pdf/2020 -03515.pdf  
The docke t folder on Regulations.gov provides access to primary and supporting 
documents for this rulemaking as well as the comments received: 
https://www.regulations.gov/docket?D=FDA -2019-N-5192 
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  21 April 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_2758_00_e.pdf