WTO notification · TBT
United StatesUpdated: check whether it is now adopted or in force
Official title
Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators
The United States issued an addendum on 17 April 2026 to the earlier TBT notification G/TBT/N/USA/1643. Addenda often report that a measure was adopted, changed, postponed or withdrawn. The measure was first notified on 14 September 2020. The comment period closed on 16 October 2020.
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Non-invasive bone growth stimulators
The comment period closed on 16 October 2020. You can still raise concerns about the measure with your country's WTO TBT enquiry point, quoting the document symbol G/TBT/N/USA/1643/Add.1; it can take them up with the United States.
Find your country's enquiry point on WTO ePing (opens in a new tab)Latest notice (G/TBT/N/USA/1643/Add.1, 17 April 2026)
Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators
Final amendment; final order - The Food and Drug Administration (FDA) is issuing a final order to reclassify non-invasive bone growth stimulators (product codes LOF and LPQ), postamendments class III devices, into class II, subject to premarket notification. FDA is codifying the reclassification of these devices under the new classification regulation, 'non-invasive bone growth stimulator.'' FDA is also establishing the special controls necessary to provide reasonable assurance of safety and effectiveness of these devices. This order is effective 18 May 2026. 91 Federal Register (FR) 20352, 16 April 2026; Title 21 Code of Federal Regulations (CFR) Part 890: This final amendment; final order and the proposed amendment; proposed order notified as G/TBT/N/USA/1643 is identified by Docket Number FDA-2020-N-1053. The Docket Folder is available from Regulations.gov at and provides access to primary and supporting documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Number.
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 II (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 reasonable 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 reduce 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.
Every notice about this measure published here, newest first. Each one is the notifying member's own text.
AddendumG/TBT/N/USA/1643/Add.1
Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators
Final amendment; final order - The Food and Drug Administration (FDA) is issuing a final order to reclassify non-invasive bone growth stimulators (product codes LOF and LPQ), postamendments class III devices, into class II, subject to premarket notification. FDA is codifying the reclassification of these devices under the new classification regulation, 'non-invasive bone growth stimulator.'' FDA is also establishing the special controls necessary to provide reasonable assurance of safety and effectiveness of these devices. This order is effective 18 May 2026. 91 Federal Register (FR) 20352, 16 April 2026; Title 21 Code of Federal Regulations (CFR) Part 890: This final amendment; final order and the proposed amendment; proposed order notified as G/TBT/N/USA/1643 is identified by Docket Number FDA-2020-N-1053. The Docket Folder is available from Regulations.gov at and provides access to primary and supporting documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Number.
Regular notificationG/TBT/N/USA/1643
Comment deadline: Closed on 16 October 2020
Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators
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 II (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 reasonable 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 reduce 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.
Expodite writes its summary from the official record. The notification and the documents it notifies are on the WTO's own websites.
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