### Question
Can you define what 180-day supplement means?


### Answer
**180-day 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 is not a panel-track supplement and requests a significant change in components, materials, design, specification, software, color additives, or labeling

#### 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**

