panel-track supplement
Defined in 1 place of the United States Code.
The term “panel-track supplement” means a supplement to an approved premarket application or premarket report under section 360e of this title that requests a significant change in design or performance of the device, or a new indication for use of the device, and for which clinical data are generally necessary to provide a reasonable assurance of safety and effectiveness.
Source
- 2002–200421 U.S.C. § 379IFood and Drugs · Definitions · for purposes of this subpart
The term “panel-track supplement” means a supplement to an approved premarket application or premarket report under section 360e of this title that requests a significant change in design or performance of the device, or a new indication for use of the device, and for which substantial clinical data are necessary to provide a reasonable assurance of safety and effectiveness.
Source
- 2004–present21 U.S.C. § 379IFood and Drugs · Definitions · for purposes of this subpart