180-day supplement
Defined in 1 dictionary — U.S. Code
United States Code
21 U.S.C. § 379I — for purposes of this subpart
The term “180-day supplement” means 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.