Public-domain · open source
OpenJurist

market clearance

Defined in 1 place of the United States Code.

The term “market clearance” includes—

(i) approval of an application under section 355, 357,1 360e, or 360j(g) of this title,

(ii) a finding of substantial equivalence under this part, and

(iii) approval of a biologics license application under subsection (a) of section 262 of title 42.

Source

  • 1997–201621 U.S.C. § 353Food and Drugs · Exemptions and consideration for certain drugs, devices, and biological products · in this section

The term “market clearance” includes—

(i) approval of an application under section 355, 357,3 360e, or 360j(g) of this title;

(ii) a finding of substantial equivalence under this part;

(iii) approval of a biologics license application under subsection (a) of section 351 of the Public Health Service Act (42 U.S.C. 262); and

(iv) de novo classification under section 360c(a)(1) of this title.

Source

  • 2016–202221 U.S.C. § 353Food and Drugs · Exemptions and consideration for certain drugs, devices, and biological products · in this section

The term “market clearance” includes—

(i) approval of an application under section 355, 357, 360e, or 360j(g) of this title,

(ii) a finding of substantial equivalence under this part, and

(iii) approval of a product or establishment license under subsection (a) or (d) of section 262 of title 42.

Source

  • 1994–199721 U.S.C. § 353Food and Drugs · Exemptions and consideration for certain drugs, devices, and biological products · in this section

The term “market clearance” includes—

(i) approval of an application under section 355, 357,4 360e, or 360j(g) of this title;

(ii) a finding of substantial equivalence under this part;

(iii) approval of a biologics license application under subsection (a) of section 351 of the Public Health Service Act (42 U.S.C. 262); and

(iv) de novo classification under section 360c(a)(1) of this title.

Source