efficacy supplement
(4) (A) The term “supplement”, with respect to a panel-track supplement, a 180-day supplement, a real-time supplement, or an efficacy supplement, means a request to the Secretary to approve a change in a device for which— (i) an application or report has been approved under section 360e(d) of this title , or an application has been approved under section 262 of title 42 ; or (ii) a notice of completion has become effective under section 360e(f) of this title . (B) 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. (C) 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. (D) The term “real-time supplement” means a supplement to an approved premarket application or premarket report under section 360e of this title that requests a minor change to the device, such as a minor change to the design of the device, software, sterilization, or labeling, and for which the applicant has requested and the agency has granted a meeting or similar forum to jointly review and determine the status of the supplement. (E) The term “efficacy supplement” means a supplement to an approved premarket application under section 262 of title 42 that requires substantive clinical data.