Medical Devices Subject to Administrative Destruction

Protection of human health or safety (TBT)

Medical devices: Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments (HS code(s): 9018); Medical equipment (ICS code(s): 11.040); Domestic safety (ICS code(s): 13.120)

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9018 - Instruments and appliances used in medical, surgical, dental or veterinary sciences, incl. scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments, n.e.s.; 9018 - Instruments and appliances used in medical, surgical, dental or veterinary sciences, incl. scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments, n.e.s.

11.040 - Medical equipment; 11.040 - Medical equipment; 13.120 - Domestic safety; 13.120 - Domestic safety

Human health; Human health

The Food and Drug Administration (FDA, Agency, or we) is issuing a regulation to implement our authority to destroy a device valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation) that has been refused admission into the United States by providing to the owner or consignee notice and an opportunity to appear and introduce testimony prior to the destruction. We are finalizing the change to our internal procedures for administrative destruction of drugs and devices. The notice of proposed rule making (NPRM) published in the Federal Register (7 October 2022).This rule is effective 1 July 2024.Title 21 Code of Federal Regulations (CFR) Part 1This final rule and the  notice of proposed rulemaking notified as G/TBT/N/USA/1934 are identified by Docket Number FDA-2021-N-1348. The Docket Folder is available on Regulations.gov at https://www.regulations.gov/docket/FDA-2021-N-1348/document and provides access to primary documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Number. 

1:File here 2:File here 3:File here 4:File here 5:File here

EN:File here

FR:File here

ES:File here

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