establishments and other facilities undertaken as part of the Secretary’s review of pending premarket applications, technology certifications, and supplements. (iv) Monitoring of research conducted in connection with the review of such applications, supplements, and submissions. (v) Review of in vitro clinical test applications subject to section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) and activities conducted in anticipation of the submission of such applications for investigational use under section 587S of the Federal Food, Drug, and Cosmetic Act (as added by section 3). (vi) The development of guidance, policy documents, or regulations to improve the process for the review of premarket applications, technology certification applications, and supplements. (vii) The development of voluntary test methods, consensus standards, or mandatory performance standards in connection with the review of such applications, supplements, or submissions and related activities. (viii) The provision of technical assistance to in vitro clinical test developers in connection with the submission of such applications, reports, supplements, or submissions. (ix) Any activity undertaken in connection with the initial classification or reclassification of an in vitro clinical test in connection with any requirement for approval or eligibility for an exemption from premarket review of an in vitro clinical test. (x) Any activity undertaken in connection with making a pathway determination of an in vitro clinical test, including the identification, establishment, and implementation of mitigation measures. (xi) Evaluation of postmarket studies required as a condition of an approval of a premarket application of an in vitro clinical test and ensuring such studies are conducted as required. (xii) Any activity undertaken in connection with ensuring in vitro clinical tests offered under an exemption from premarket review pursuant to section 587C or 587G meet the criteria for such exemption and the applicable standard. (xiii)