; or (B) subject to the requirements of this subchapter and 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. (2) Inapplicability to other tests Notwithstanding paragraph (1), 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. (3) Further development A component, part, or raw material (as described in paragraph (1)) 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