00079 VALID Act Parts and Components for Further Development
From VALID Act
“(b) Components and Parts.—
“(1) EXEMPTION.—
“(A) IN GENERAL.—Subject to subparagraph (B), a component, part, or raw material described in section 201(ss)(1)(B)(v) is exempt from the requirements of this subchapter if it is—
“(i) intended for further development as described in paragraph (2); or
“(ii) otherwise to be regulated based on its risk when used as intended by the developer, notwithstanding its subsequent use by a developer as a component, part, or raw material of another in vitro clinical test.
“(B) INAPPLICABILITY TO OTHER TESTS.—Notwithstanding subparagraph (A), an in vitro clinical test that is described in section 201(ss)(1)(B) and that uses a component or part described in such subparagraph shall be subject to the requirements of this subchapter, unless the test is otherwise exempt under this section.
“(2) FURTHER DEVELOPMENT.—A component, part, or raw material (as described in paragraph (1)(A)) is intended for further development (for purposes of such paragraph) if—
“(A) it is intended solely for use in the development of another in vitro clinical test; and
“(B) in the case of such a test that is introduced or delivered for introduction into interstate commerce after the date of enactment of the Verifying Accurate Leading-edge IVCT Development Act of 2021, the labeling of such test bears the following statement: ‘This product is intended solely for further development of an in vitro clinical test and is exempt from FDA regulation. This product must be evaluated by the in vitro clinical test developer if it is used with or in the development of an in vitro clinical test.’.
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