G/TBT/N/USA/1643  
14 September 2020  
(20-6143) 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) [1672]  
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):  Non-
invasive bone growth stimulators; Medical equipment (ICS 11.040)  
5. Title, number of pages and language(s) of the notified document:  Physical 
Medicine Devices; Reclassification of Non -Invasive Bone Growth Stimulators (9 page(s), 
in English)  
6. Descr iption of content:  Proposed amendment; proposed order; request for comments 
- The Food and Drug Administration (FDA) is proposing to reclassify non -invasive bone 
growth stimulators, postamendments class III devices (product codes LOF and LPQ), into 
class I I (special controls), subject to premarket notification. FDA is also proposing a new 
device classification with the name "non -invasive bone growth stimulators" along with the 
proposed special controls that the Agency believes are necessary to provide a rea sonable 
assurance of safety and effectiveness of these devices. FDA is proposing this 
reclassification on its own initiative. If finalized, this order will reclassify these devices 
from class III (premarket approval) to class II (special controls) and redu ce the regulatory 
burdens associated with these devices, as these devices will no longer be required to 
submit a premarket approval application (PMA), but are subject to premarket notification 
(510(k)) requirements and general and special controls.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  
8. Relevant documents:   
85 Federal Register (FR) 49986, 17 August 2020; Title  21 Code of Federal Regulations 
(CFR) Part 890:  
https://www.govinfo.gov/content/pkg/FR -2020-08-17/html/2020 -17543.htm  
https://www.govinfo.gov/content/pkg/FR -2020-08-17/pdf/2020 -17543.pdf  
This proposed amendment; proposed order; request for comments is identified by Docket 
Number FDA -2020-N-1053. The Docket Folder is available on Regulations.gov  at G/TBT/N/USA/1643  
 
- 2 - 
 
  https://www.regulations.gov/docket?D=FDA -2020-N-1053 and provides access to 
primary and supporting documents as well as comments receive d. 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 . 
Comments received by the USA TBT Enquiry 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:  16 October 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_5398_00_e.pdf