Test Article [Food and Drugs] Law and Legal Definition

Pursuant to 21 CFR 50.3 (j) [Title 21 Food and Drugs; Chapter I Food and Drug Administration, Department of Health and Human Services; Subchapter A General; Part 50 Protection of Human Subjects; Subpart A General Provisions], Test Article means any drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the act or under sections 351 and 354-360F of the Public Health Service Act (42 U.S.C. 262 and 263b-263n).