CLEAR Act
Bill: S.4333 | Sponsor: Sen. Smith, Tina (D-MN)
Policy area: Health

Summary:
Consistent Legal Evaluation And Regulation of Medical Products Act or the CLEAR Act
This bill requires the Food and Drug Administration to regulate contrast agents for medical imaging devices, radioactive drugs, over-the-counter monograph drugs, and ophthalmic drug articles (i.e., eye droppers) as drugs rather than medical devices.

To deem certain products regulated by the Food and Drug Administration 
                               as drugs.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Consistent Legal Evaluation And 
Regulation of Medical Products Act'' or the ``CLEAR Act''.

SEC. 2. REGULATION OF CERTAIN PRODUCTS AS DRUGS.

    (a) In General.--Section 503 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 353) is amended by adding at the end the 
following:
    ``(h) Deeming Certain Products as Drugs.--
            ``(1) In general.--Any contrast agent, radioactive drug, 
        OTC monograph drug, or ophthalmic drug article shall be deemed 
        to be a drug under section 201(g) and not a device under 
        section 201(h).
            ``(2) Definitions.--For purposes of this subsection--
                    ``(A) the term `contrast agent' means an article 
                that is intended for use in conjunction with an 
                applicable medical imaging device, and--
                            ``(i) is a diagnostic radiopharmaceutical, 
                        as defined in section 315.2 and 601.31 of title 
                        21, Code of Federal Regulations (or any 
                        successor regulations); or
                            ``(ii) is a diagnostic agent that improves 
                        the visualization of structure or function 
                        within the body by increasing the relative 
                        difference in signal intensity within the 
                        target tissue, structure, or fluid;
                    ``(B) the term `ophthalmic drug article' means any 
                eye cup, eye dropper, or other non-invasive and non-
                implanted dispenser intended for ophthalmic use if 
                packaged with the drug with which such article is 
                intended to be used;
                    ``(C) the term `OTC monograph drug' has the meaning 
                given such term in section 744L; and
                    ``(D) the term `radioactive drug' has the meaning 
                given such term in section 310.3(n) of title 21, Code 
                of Federal Regulations (or any successor regulations), 
                except that such term does not include--
                            ``(i) implants or articles similar to an 
                        implant;
                            ``(ii) articles that apply radiation from 
                        outside of the body; or
                            ``(iii) the radiation source of an article 
                        described in clause (i) or (ii).
            ``(3) No effect on determinations regarding other drugs or 
        devices.--Paragraph (1) shall not be construed as bearing on, 
        or being relevant to, the question of whether any product other 
        than a drug described in such paragraph is a device as defined 
        by section 201(h) or a drug as defined by section 201(g).''.
    (b) Application.--The amendment made by subsection (a) shall apply 
to any application submitted under subsection (b) or (j) of section 505 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and to any 
application submitted under subsection (a) or (k) of section 351 of the 
Public Health Service Act (42 U.S.C. 262), whether such submission was 
prior to, on, or after the date of enactment of this Act, and shall 
apply to all actions pending on the day of enactment of this Act.
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