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21 U.S. Code § 379i. Definitions
For purposes of this subpart:(1) The term “premarket application” means—
(A)
an application for approval of a device submitted under section 360e(c) of this title or section 262 of title 42; or
(B)
a product development protocol described in section 360e(f) of this title.
Such term does not include a supplement, a premarket report, or a premarket notification submission.
(2)
The term “premarket report” means a report submitted under section 360e(c)(2) of this title.
(3)
The term “premarket notification submission” means a report submitted under section 360(k) of this title.
(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.