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Regulations last checked for updates: Jan 12, 2026
Title 21 - Food and Drugs last revised: Dec 18, 2026
All Titles
Title 21
Chapter I
Part 809
Subpart B - Subpart B—Labeling
§ 809.10 - Labeling for in vitro diagnostic products.
§ 809.11 - Exceptions or alternatives to labeling requirements for in vitro diagnostic products for human use held by the Strategic National Stockpile.
authority:
21 U.S.C. 321
(h)(1), 331, 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 371, 372, 374, 381, and
42 U.S.C. 262.
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