00084 VALID Act Pre-Market Review Requirement
From VALID Act SEC. 587B. Premarket review.
“(a) In general.—No person shall introduce or deliver for introduction into interstate commerce any in vitro clinical test, unless—
“(1) an approval of an application filed pursuant to subsection (c) or (d) is effective with respect to test; or
“(2) the test is exempt under section 587A from premarket review under this section.
“(b) Transparency and predictability.—
“(1) PRE-SUBMISSION MEETING OR REQUEST FOR INFORMAL FEEDBACK.—Pursuant to section 587H, prior to filing an application under subsection (c) or (d), any person may request a meeting or written correspondence with the Secretary to discuss the eligibility of an in vitro clinical test for premarket review or other information related to the filing of an application. The Secretary shall respond to such request within 45 calendar days.
“(2) STREAMLINING OF APPLICATIONS.—
“(A) PREMARKET APPLICATION AND TECHNOLOGY CERTIFICATION.—If a person files a premarket application under this section and provides any additional documentation required under section 587D, the in vitro clinical test that is the subject of the application may be utilized as the representative test reviewed by the Secretary to provide an approval for both a premarket application under this section and a technology certification order under section 587D.
“(B) REPRESENTATIVE ASSAYS FOR PREMARKET APPROVAL.—With respect to a technology certification application filed under section 587D, the representative test, as described in subparagraph (A), used to issue a technology certification order under section 587D shall be deemed a test with premarket approval under this section.
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