G/TBT/N/USA/1607  
20 April 2020  
(20-3091) 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) [1637]  
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):  
Nucleic  acid-based hepatitis C virus (HCV) ribonucleic acid (RNA) 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 Nucleic Acid -Based Hepatitis C Virus Ribonucleic Acid 
Assay  Devices, To Be Renamed Nucle ic Acid -Based Hepatitis C Virus Ribonucleic Acid Tests 
(8 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 nucleic acid -
based hepatitis C virus (HCV) ribonucleic acid (RNA) devices intended for the qualitative or 
quantitative detection or genotyping of HCV RNA, postamendments class III devices 
(product codes MZP and OBF), into class II (general controls and special controls) , subject 
to premarket notification. FDA is also proposing a new device classification regulation with 
the name "nucleic acid -based Hepatitis C virus (HCV) ribonucleic acid tests" along with the 
special controls that the Agency believes are necessary to pr ovide a reasonable assurance 
of safety and effectiveness for these devices. 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 approva l) to class II (general controls and 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 premarke t notification (510(k)) and obtain 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/1607  
 
- 2 - 
 
  8. Relevant documents:   
• 85 Federal Register (FR) 18483, 2 April 2020; Title  21 Code of Federal Regulations 
(CFR) Part 866:  
https://www.govinfo.gov/content/pkg/FR -2020-04-02/html/2020 -06820.htm  
https://www.govinfo.gov/content/pkg/FR -2020-04-02/pdf/2020 -06820.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-
1088. 
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_2760_00_e.pdf