G/TBT/N/USA/1608  
20 April 2020  
(20-3089) 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) [1638]  
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):  Hepatitis C 
virus (HCV) antibody assay devices; 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 Certain Hepatitis C Virus Antib ody Assays Devices, To Be 
Renamed Hepatitis C Virus Antibody Tests (7 page(s), in English)  
6. Description of content:  Proposed amendment; proposed order; request for comments - 
The Food and Drug Administration (FDA or Agency) is proposing to reclassify ce rtain 
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 also pr oposing a new device 
classification regulation with the name "hepatitis C virus (HCV) antibody tests" along with 
the special controls that the Agency believes are necessary to provide a reasonable 
assurance of safety and effectiveness for these devices. FD A 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 regulato ry 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 under the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) and o btain clearance before marketing 
their device.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety; Quality requirements; Harmonization  G/TBT/N/USA/1608  
 
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  8. Relevant documents:   
• 85 Federal Register (FR) 18490, 2 April 2020; Title  21 Code of Federal Regulations 
(CFR) Part 866:  
https://www.govinfo.gov/content/pkg/FR -2020-04-02/html/2020 -06821.htm  
https://www.govinfo.gov/content/pkg/FR -2020-04-02/pdf/2020 -06821.pdf  
The docket folder on Regulations.gov provides access to primary and supporting 
documents for this rulemaking: https://www.regulations.gov/docket?D=FDA -2020-N-
1082. 
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  1 June 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/crnattachments/2020/TBT/USA/20_2761_00_e.pdf