process for the review of device applications

(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 tosection 262 of title 42for an investigational new drug application undersection 355(i) of this titleor for an investigational device exemption undersection 360j(g) of this titleand activities conducted in anticipation of the submission of such applications under (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 undersection 360d of this titlein 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 underin connection with the initial classification or reclassification of a device or undersection 360e(b) of this titlein 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 undersection 360e of this titleor a premarket application undersection 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.

Source

21 USC § 379i(8)


Scoping language

None: Default is title Scope
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