For purposes of this subpart:
(1) The term “premarket application” means—
Such term does not include a supplement, a premarket report, or a premarket notification submission.
(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.
(E) The term “efficacy supplement” means a supplement to an approved premarket application under section 262 of title 42 that requires substantive clinical data.
(5) The term “30-day notice” means a notice under section 360e(d)(5) 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” “de novo classification request” 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 a request made under section 360d 360c(f)(2)(A) of this title in connection with the review of such applications, reports, supplements, or submissions and related activities. (H) The provision of technical assistance respect 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. (J) Evaluation of postmarket studies required as a condition of an approval of a premarket application or premarket report under section 360e of this title or a premarket application under section 262 of title 42 . (K) Compiling, developing, and reviewing information on relevant devices to identify safety and effectiveness issues for devices subject to premarket applications, premarket reports, supplements, or premarket notification submissions.
(9) The term “costs of resources allocated for the process “process for the review of device applications” means the expenses in connection following activities of the Secretary with respect to the process review of premarket applications, premarket reports, supplements, premarket notification submissions, and de novo classification requests: (A) The activities necessary for the review of device applications for— (A) officers premarket applications, premarket reports, supplements, and employees premarket notification submissions. (B) The issuance of action letters that allow the Food 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 Drug Administration, contractors other facilities undertaken as part of the Food Secretary’s review of pending premarket applications, premarket reports, and Drug Administration, advisory committees, supplements. (D) Monitoring of research conducted in connection with the review of such applications, reports, supplements, submissions, and costs related de novo classification requests. (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 officers, employees, 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, premarket notification submissions, and committees de novo classification requests. (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, submissions, or requests and related activities. (H) The provision of technical assistance to contracts device manufacturers in connection with the submission of such contractors; (B) management applications, reports, supplements, submissions, or requests. (I) Any activity undertaken under section 360c or 360e(i) of information, and this title in connection with the acquisition, maintenance, and repair initial classification or reclassification of computer resources; (C) leasing, maintenance, renovation, and repair a device or under section 360e(b) of facilities and acquisition, maintenance, and repair this title in connection with any requirement for approval of fixtures, furniture, scientific equipment, and other necessary materials and supplies; a device. (J) Evaluation of postmarket studies required as a condition of an approval of a premarket application or premarket report under section 360e of this title or a premarket application under section 262 of title 42 . (K) Compiling, developing, and (D) collecting fees reviewing information on relevant devices to identify safety and accounting for resources allocated effectiveness issues for the review of devices subject to premarket applications, premarket reports, supplements, and submissions. premarket notification submissions, or de novo classification requests.
(10) The term “adjustment factor” applicable to a fiscal year is “costs of resources allocated for the Consumer Price Index process for all urban consumers (all items; United States city average) the review of device applications” means the expenses in connection with the process for October the review of device applications for— (A) officers and employees of the preceding fiscal year divided by Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such Index officers, employees, and committees and to contracts with such contractors; (B) management of information, and the acquisition, maintenance, and repair of computer resources; (C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and (D) collecting fees and accounting for October 2011. resources allocated for the review of premarket applications, premarket reports, supplements, submissions, and de novo classification requests.
(11) The term “person” includes an affiliate thereof. “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 2021.
(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— (A) one business entity controls, or has the power to control, the other business entity; or (B) a third party controls, or has power to control, both of the business entities. “person” includes an affiliate thereof.
(13) The term “establishment subject to a registration fee” “affiliate” means an establishment a business entity that is registered (or is required to register) has a relationship with a second business entity (whether domestic or international) if, directly or indirectly— (A) one business entity controls, or has the Secretary under section 360 of this title because such establishment is engaged in power to control, the manufacture, preparation, propagation, compounding, other business entity; or processing of (B) a device. third party controls, or has power to control, both of the business entities.
(14) The term “establishment subject to a registration fee” means an establishment that is registered (or is required to register) with the Secretary under section 360 of this title because such establishment is engaged in the manufacture, preparation, propagation, compounding, or processing of a device.
