II 

117TH CONGRESS 

2D SESSION S. 4333 

To deem certain products regulated by the Food and Drug Administration 

as drugs. 

IN THE SENATE OF THE UNITED STATES 

MAY 26, 2022 

Ms. SMITH (for herself and Mr. MARSHALL) introduced the following bill; 

which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To deem certain products regulated by the Food and Drug 

Administration as drugs. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Consistent Legal Eval5 uation And Regulation of Medical Products Act’’ or the 

6 ‘‘CLEAR Act’’. 

7 SEC. 2. REGULATION OF CERTAIN PRODUCTS AS DRUGS. 

8 (a) IN GENERAL.—Section 503 of the Federal Food, 

9 Drug, and Cosmetic Act (21 U.S.C. 353) is amended by 

10 adding at the end the following: 


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1 ‘‘(h) DEEMING CERTAIN PRODUCTS AS DRUGS.— 

2 ‘‘(1) IN GENERAL.—Any contrast agent, radio3 active drug, OTC monograph drug, or ophthalmic 

4 drug article shall be deemed to be a drug under sec5 tion 201(g) and not a device under section 201(h). 

6 ‘‘(2) DEFINITIONS.—For purposes of this sub7 section— 

8 ‘‘(A) the term ‘contrast agent’ means an 

9 article that is intended for use in conjunction 

10 with an applicable medical imaging device, 

11 and— 

12 ‘‘(i) is a diagnostic radiopharma13 ceutical, as defined in section 315.2 and 

14 601.31 of title 21, Code of Federal Regula15 tions (or any successor regulations); or 

16 ‘‘(ii) is a diagnostic agent that im17 proves the visualization of structure or 

18 function within the body by increasing the 

19 relative difference in signal intensity within 

20 the target tissue, structure, or fluid; 

21 ‘‘(B) the term ‘ophthalmic drug article’ 

22 means any eye cup, eye dropper, or other non23 invasive and non-implanted dispenser intended 

24 for ophthalmic use if packaged with the drug 

25 with which such article is intended to be used; 


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1 ‘‘(C) the term ‘OTC monograph drug’ has 

2 the meaning given such term in section 744L; 

3 and 

4 ‘‘(D) the term ‘radioactive drug’ has the 

5 meaning given such term in section 310.3(n) of 

6 title 21, Code of Federal Regulations (or any 

7 successor regulations), except that such term 

8 does not include— 

9 ‘‘(i) implants or articles similar to an 

10 implant; 

11 ‘‘(ii) articles that apply radiation from 

12 outside of the body; or 

13 ‘‘(iii) the radiation source of an article 

14 described in clause (i) or (ii). 

15 ‘‘(3) NO EFFECT ON DETERMINATIONS RE16 GARDING OTHER DRUGS OR DEVICES.—Paragraph 

17 (1) shall not be construed as bearing on, or being 

18 relevant to, the question of whether any product 

19 other than a drug described in such paragraph is a 

20 device as defined by section 201(h) or a drug as de21 fined by section 201(g).’’. 

22 (b) APPLICATION.—The amendment made by sub23 section (a) shall apply to any application submitted under 

24 subsection (b) or (j) of section 505 of the Federal Food, 

25 Drug, and Cosmetic Act (21 U.S.C. 355) and to any appliVerDate Sep 11 2014 02:08 Jun 03, 2022 Jkt 029200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S4333.IS S4333

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1 cation submitted under subsection (a) or (k) of section 

2 351 of the Public Health Service Act (42 U.S.C. 262), 

3 whether such submission was prior to, on, or after the date 

4 of enactment of this Act, and shall apply to all actions 

5 pending on the day of enactment of this Act. 

Æ 


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