G/TBT/N/USA/2054  
4 October 2023  
(23-6658) 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 AMERICA  
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) [2085]  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the no tification 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 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  In vitro 
diagnostic products; Medical equipment (ICS code(s): 11.040); In vitro diagnostic test 
systems (ICS code(s): 11.100.10)  
5. Title, number of pages and language(s) of the notified document:  Medical Devices; 
Laboratory Developed Tests; (26 page(s), in English)  
6. Description of content : Proposed rule - The Food and Drug Administration (FDA, the 
Agency, or we) is proposing to amend its regulations to make explicit that in vitro 
diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) including when  the manufacturer of the IVD is a laboratory. In conjunction 
with this amendment, FDA is proposing a policy under which FDA intends to phase out its 
general enforcement discretion approach for laboratory developed tests (LDTs) so that 
IVDs manufactured by a laboratory would generally fall under the same enforcement 
approach as other IVDs. FDA is proposing this phaseout to better protect the public health 
by helping to assure the safety and effectiveness of LDTs. If finalized, this phaseout may 
also foster t he manufacturing of innovative IVDs for which FDA has determined there is 
a reasonable assurance of safety and effectiveness.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  
8. Relevant documents:   
88 Federal Register (FR) 68006, 3 October 2023; Title 21 Code of Federal Regulations 
(CFR) Part 809 : 
https://www.govinfo.gov/content/pkg/FR -2023-10-03/html/2023 -21662.htm  
https://www.govinfo.gov/content/pkg/FR -2023-10-03/pdf/2023 -21662.pdf  G/TBT/N/USA/2054  
 
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  This proposed rule is identified by Docket Number FDA -2023-N-2177. The Docket Folder 
is available on Regulations.gov at https://www.regulations.go v/docket/FDA -2023-N-
2177/document  and provides access to primary documents as well as comments received. 
Documents are also accessible from Regulations.gov  by searching the Docket Number. 
WTO Members and their stakeholders are asked to submit comments to the USA TBT 
Enquiry Point  by or before 4pm Eastern Time  on 4 December 2023. Comments received 
by the USA TBT E nquiry Point from WTO Members and their stakeholders will be shared 
with the regulator and will also be submitted to the Docket  on Regulations.gov  if received 
within the comment period.  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  4 December 2023  
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/2023/TBT/USA/23_1280 6_00_e.pdf