00089 VALID Act Approval Process Go-No-Go Factors
From VALID Act “SEC. 587B. Premarket review.
“(2) APPROVAL OF AN APPLICATION.—
“(A) IN GENERAL.—The Secretary shall approve an application submitted under subsection (c) with respect to an in vitro clinical test if the Secretary finds that there is a reasonable assurance that the applicable standard is met, and—
“(i) except as provided under subsection (d), the applicant is in compliance with applicable quality requirements in section 587J or as otherwise specified in a condition of approval, or maintains the documentation required to be in compliance with such requirements if the applicant is not required to submit such documentation as a part of the application under this section;
“(ii) the application does not contain a false statement of material fact;
“(iii) based on a fair evaluation of all material facts, the proposed labeling is truthful and non-misleading and complies with the requirements of section 587K;
“(iv) except as provided under subsection (d), the applicant permits, if requested, authorized employees of the Food and Drug Administration and persons accredited under section 587P an opportunity—
“(I) to inspect at a reasonable time and in a reasonable manner the facilities and all pertinent equipment, finished and unfinished materials, containers, and labeling therein, including all things (including records, files, papers, and controls) bearing on whether an in vitro clinical test is adulterated, misbranded, or otherwise in violation of this Act; and
“(II) to view and to copy and verify all records pertinent to the application and the in vitro clinical test;
“(v) the test conforms with any applicable performance standards under section 587Q and any applicable mitigating measures under section 587E; and
“(vi) all nonclinical laboratory studies and clinical investigations involving human subjects that are described in the application were conducted in a manner that meets the requirements of this section.
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