00057 VALID Act- Applicability & Overlap with CLIA
“SEC. 587A. Applicability.
“(a) In general.—
“(1) APPLICABILITY OF THIS SUBCHAPTER.—
“(A) IN GENERAL.—An in vitro clinical test shall be subject to the requirements of this subchapter, except as otherwise provided this subchapter. ….
“(C) NON-APPLICABLE REQUIREMENT.—Subject to any exemption or exclusion in this section, an in vitro clinical test shall not be subject to any provision or requirement of this Act other than this subchapter unless such other provision or requirement—
“(i) applies expressly to in vitro clinical tests; or
“(ii) describes the authority of the Secretary when regulating such in vitro clinical tests or subset of in vitro clinical tests, with respect to—
“(I) all articles regulated by the Secretary pursuant to this Act; or
“(II) a subset of such articles that includes in vitro clinical tests.
[In other word, just b/c IVCTs are now covered by FDCA, doesn’t mean 21 CFR Part 820, 812, 11, 50, 54, 56, etc. apply unless this is EXPLICITLY stated they apply to IVCTs.]
“(2) LABORATORIES AND BLOOD AND TISSUE ESTABLISHMENTS.—
“(A) RELATION TO LABORATORY CERTIFICATION PURSUANT TO SECTION 353 OF THE PHSA.—Nothing in this subchapter shall be construed to modify the authority of the Secretary with respect to laboratories or clinical laboratories under section 353 of the Public Health Service Act.
“(B) AVOIDING DUPLICATION.—In implementing this subchapter, the Secretary shall avoid issuing or enforcing regulations that are duplicative of regulations under section 353.
“(C) BLOOD AND TISSUE.—Nothing in this subchapter shall be construed to modify the authority of the Secretary with respect to laboratories, establishments, or other facilities to the extent they are engaged in the propagation, manufacture, or preparation, including filling, testing, labeling, packaging, and storage, of blood, blood components, human cells, tissues, or tissue products under this Act or section 351 or 361 of the Public Health Service Act.
“(3) PRACTICE OF MEDICINE.—
“(A) IN GENERAL.—Nothing in this subchapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed in vitro clinical test for any condition or disease within a health care practitioner-patient relationship pursuant to applicable Federal or State law.
“(B) RULES OF CONSTRUCTION.—
“(i) SALE, DISTRIBUTION, LABELING.—Nothing in this paragraph shall be construed to limit the authority of the Secretary to establish or enforce restrictions on the sale, distribution, or labeling of an in vitro clinical test under this Act.
“(ii) PROMOTION OF UNAPPROVED USES.—Nothing in this paragraph shall be construed to alter any prohibition on the promotion of unapproved uses of legally marketed in vitro clinical tests.
[In other word, these rules won’t duplicate or conflict with CMS / CLIA licensing requirements, blood and tissue rules, practice of medicine, but can still prohibit promotion/sales of IVCTs.]
“(6) EFFECT ON OTHER LAWS.—Any in vitro clinical test that is lawfully marketed under this Act, including tests that are approved under section 587B, cleared pursuant to an active technology certification order under section 587D, or exempt from premarket review under an exemption in this section, shall be eligible for introduction into interstate commerce except as otherwise provided in this subchapter.
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