United States of America | Medical Devices Subject to Administrative Destruction

Title of document
Medical Devices Subject to Administrative Destruction

Description
Notice of Proposed Rulemaking - The Food and Drug Administration (FDA, Agency, or we) is proposing a regulation to implement its new 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 under the Federal Food, Drug, and Cosmetic Act (FD&C Act 21 USC Ch. 9), by providing to the owner or consignee notice and an opportunity to appear and introduce testimony prior to the destruction. Once finalized, this regulation will allow FDA to better protect the public health by preventing re-importation and deterring future shipments of refused devices subject to administrative destruction. We also discuss in this Notice of Proposed Rulemaking our intent to change FDA's procedures for administrative destruction of drugs and, if this proposed rule is finalized, these procedures will also include devices subject to administrative destruction. We described our current procedures in the proposed and final rules entitled "Administrative Destruction of Certain Drugs Refused Admission to the United States."

Notifying member: United States of America

Notification: G/TBT/N/USA/1934

Objective tag
Protection of human health or safety (TBT)

Documents

• 22_7094_00_e.pdf

Timing:

• Submission: N/A
• Reception: N/A
• Distribution: 20/10/2022
• Final date for comments: N/A
• Proposed date of adoption: N/A