panel-track supplement
Defined in 1 dictionary — U.S. Code
United States Code
21 U.S.C. § 379I — for purposes of this subpart (2 versions over time)
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.