Sec. 3. Importation of devices in shortage
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Section 801(d) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381(d) ) is amended— in paragraph (1), by adding at the end the following subparagraph: Except as authorized by the Secretary in the case of a device that appears on the drug and device shortage list under section 506E, no device may be imported into the United States for commercial use if such device is manufactured outside the United States, unless the manufacturer has authorized the device to be marketed in the United States and has caused the device to be labeled to be marketed in the United States. ; and in paragraph (2), by striking drug each place it appears and inserting drug or device .
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Sec. 3
Importation of devices in shortage
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