### Question
Can you define what panel-track supplement means?


### Answer
**Panel-track supplement** is defined as the following in *21 U.S.C. § 379i*:

> 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

#### Citation:
  - *21 U.S.C. § 379i*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER VII-GENERAL AUTHORITY > Part C-Fees > subpart 3-fees relating to devices**

