The Secretary shall-
In this section, the term "medical product" means a drug, as defined in subsection (g) of section 321 of this title, a device, as defined in subsection (h) of such section, or a biological product, as defined in section 351(i) of the Public Health Service Act [42 U.S.C. 262(i)] .
Nothing in this section shall alter the criteria for evaluating the safety or effectiveness of a medical product under this chapter or under the Public Health Service Act [42 U.S.C. 201 et seq.].
21 U.S.C. § 360bbb-8a
EDITORIAL NOTES
REFERENCES IN TEXTThe Public Health Service Act, referred to in subsec. (c), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.
AMENDMENTS2016-Subsec. (c). Pub. L. 114-255 inserted "or under the Public Health Service Act" before period at end.