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# Device Export Foreign Approval Letters Info Collection
- URL: https://www.fdaweb.com/device-export-foreign-approval-letters-info-collection/
- Published: 2022-01-28T12:00:00.000Z
- Updated: 2026-09-14T17:30:28.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5151032

*Federal Register* notice: FDA is seeking comments on an information collection extension entitled “Export of Medical Devices; Foreign Letters of Approval” (OMB Control Number 0910-0264). Section 801(e)(2) of the Federal Food, Drug, and Cosmetic Act provides for the exportation of an unapproved device under certain circumstances. The agency requires written authorization from the appropriate office within the foreign government approving the device importation. An alternative to obtaining written authorization from the foreign government is to accept a notarized certification from the responsible company that the product is not in conflict with the foreign country’s laws. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-01-28/pdf/2022-01793.pdf?ref=fdaweb.com).