Health and Human Services Department Docket FDA-2021-N-1348 Proposed Rule

2022-21809: Administrative Destruction

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Summary

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), 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."

The agency’s own summary, as published.

What this changes

Amends 1 part of the Code of Federal Regulations — the standing rules this notice rewrites.

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