; and (2) the use of three-dimensional human tissue models for preclinical, clinical, and postmarket safety and efficacy testing, labeling, or other uses by product sponsors. (b) Periodic updates The Secretary shall periodically update the guidance issued under subsection (a). 4. Rule of construction Nothing in this Act shall be construed to prohibit or limit the use of three-dimensional human tissue models by product sponsors with respect to— (1) obtaining approval or licensure of a drug or biological product, including a combination product, under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) or section 351 of the Public Health Service Act ( 42 U.S.C. 262 ); or (2) meeting the requirements of a regulatory decision issued by the Secretary of Health and Human Services. 5. Definitions In this Act: (1) Biological product The term biological product has the meaning given such term in section 351(i) of the Public Health Service Act ( 42 U.S.C. 262(i) ). (2) Combination product The term combination product means a combination product described in section 503(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 353(g) ). (3) Drug The term drug has the meaning given such term in section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 ). (4) Three-dimensional human tissue model The term three-dimensional human tissue model means a three-dimensional model that— (A) approximates human tissue composition and physiology using spatially controlled deposition of adult human cells or cell-containing materials in user-defined, geometric patterns; (B) can be used to detect toxicity that is not identifiable in animal models; (C) can be used to test the efficacy of a drug that is not possible or not able to be sufficiently tested in an animal model; and (D) can predict toxicity in clinical testing or detect toxicity in known clinical failures.