§ 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
Such term does not include a supplement, a premarket report, or a premarket notification submission.
(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—
(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.
(5)
The term “30-day notice” means a notice under section
360e
(d)(6) of this title that is limited to a request to make modifications to manufacturing procedures or methods of manufacture affecting the safety and effectiveness of the device.
(6)
The term “request for classification information” means a request made under section
360c
(g) of this title for information respecting the class in which a device has been classified or the requirements applicable to a device.
(7)
The term “annual fee”, for periodic reporting concerning a class III device, means the annual fee associated with periodic reports required by a premarket application approval order.
(8)
The term “process for the review of device applications” means the following activities of the Secretary with respect to the review of premarket applications, premarket reports, supplements, and premarket notification submissions:
(A)
The activities necessary for the review of premarket applications, premarket reports, supplements, and premarket notification submissions.
(B)
The issuance of action letters that allow the marketing of devices or which set forth in detail the specific deficiencies in such applications, reports, supplements, or submissions and, where appropriate, the actions necessary to place them in condition for approval.
(C)
The inspection of manufacturing establishments and other facilities undertaken as part of the Secretary’s review of pending premarket applications, premarket reports, and supplements.
(D)
Monitoring of research conducted in connection with the review of such applications, reports, supplements, and submissions.
(E)
Review of device applications subject to section
262 of title
42 for an investigational new drug application under section
355
(i) of this title or for an investigational device exemption under section
360j
(g) of this title and activities conducted in anticipation of the submission of such applications under section
355
(i) or
360j
(g) of this title.
(F)
The development of guidance, policy documents, or regulations to improve the process for the review of premarket applications, premarket reports, supplements, and premarket notification submissions.
(G)
The development of voluntary test methods, consensus standards, or mandatory performance standards under section
360d of this title in connection with the review of such applications, reports, supplements, or submissions and related activities.
(H)
The provision of technical assistance to device manufacturers in connection with the submission of such applications, reports, supplements, or submissions.
(I)
Any activity undertaken under section
360c or
360e
(i) of this title in connection with the initial classification or reclassification of a device or under section
360e
(b) of this title in connection with any requirement for approval of a device.
(9)
The term “costs of resources allocated for the process for the review of device applications” means the expenses incurred in connection with the process for the review of device applications for—
(A)
officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers, employees, and committees and to contracts with such contractors;
(10)
The term “adjustment factor” applicable to a fiscal year is the Consumer Price Index for all urban consumers (all items; United States city average) for October of the preceding fiscal year divided by such Index for October 2001.
(12)
The term “affiliate” means a business entity that has a relationship with a second business entity (whether domestic or international) if, directly or indirectly—
(13)
The term “establishment subject to a registration fee” means an establishment that is required to register with the Secretary under section
360 of this title and is one of the following types of establishments:
(A)
Manufacturer
An establishment that makes by any means any article that is a device, including an establishment that sterilizes or otherwise makes such article for or on behalf of a specification developer or any other person.
(B)
Single-use device reprocessor
An establishment that, within the meaning of section
321
(ll)(2)(A) of this title, performs additional processing and manufacturing operations on a single-use device that has previously been used on a patient.
(C)
Specification developer
An establishment that develops specifications for a device that is distributed under the establishment’s name but which performs no manufacturing, including an establishment that, in addition to developing specifications, also arranges for the manufacturing of devices labeled with another establishment’s name by a contract manufacturer.