contrast agent
Defined in 3 places of the United States Code.
the term “contrast agent” means a drug that is approved under section 355 of this title or licensed under section 262 of title 42, is intended for use in conjunction with an applicable medical imaging device, and—
(i) is a diagnostic radiopharmaceutical, as defined in section 2 315.2 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.
Source
- 2017–202221 U.S.C. § 360JFood and Drugs · General provisions respecting control of devices intended for human use · under this chapter
the term “contrast agent” means a drug that is approved under section 355 of this title or licensed under section 262 of title 42, is intended for use in conjunction with an applicable medical imaging device, and—
(i) is a diagnostic radiopharmaceutical, as defined in section 3 315.2 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.
Source
- 2022–present21 U.S.C. § 360JFood and Drugs · General provisions respecting control of devices intended for human use · under this chapter
the term “contrast agent” means a drug that is approved under section 355 of this title or licensed under section 262 of title 42, 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.
Source
- 2017–201821 U.S.C. § 360JFood and Drugs · General provisions respecting control of devices intended for human use · under this chapter
The term "contrast agent" means an article that is intended for use in conjunction with a medical imaging device, and—
(i) is a diagnostic radiopharmaceutical, as defined in sections 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.
Source
- 2022–present21 U.S.C. § 353Food and Drugs · Exemptions and consideration for certain drugs, devices, and biological products · in this section
the terms “applicable medical imaging device” and “contrast agent” have the meanings given such terms in section 360j(p) of this title.
Source
- 2017–present21 U.S.C. § 355Food and Drugs · New drugs · under this section