EUA Law

Any product, medical device, medicine, vaccine, or medical test that is designated EUA approved status by the FDA is regulated under Title 21 of the United States Code (Federal Law).

Title 21 U.S.C. § 360bbb-3(e)(1)(A)(ii)(I-III)

Federal law regarding EUA Products (<emphasis added)

(ii) Appropriate conditions designed to ensure that individuals to whom the product is administered are informed—

(I) that the Secretary has authorized the emergency use of the product;

(II) of the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown; and

(III) of the option to accept or refuse administration of the product, of the consequences (<health related), if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.

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