Page:United States Statutes at Large Volume 116 Part 2.djvu/808

 116 STAT. 1590 PUBLIC LAW 107-250—OCT. 26, 2002 the device, and for which clinical data are generally 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 515 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 515 that requests a minor change to the device, such as a minor change to the design of the device, software, manufacturing, 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 351 of the Public Health Service Act that requires substantive clinical data. "(5) 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 351 of the Public Health Service Act for an investigational new drug application under section 505(i) or for an investigational device exemption under section 520(g) and activities conducted in anticipation of the submission of such applications under section 505(i) or 520(g). "(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 514 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.

�