; (C) is not a high-risk test, or is a high-risk test that the Secretary has determined meets at least one condition in paragraph (2) and is otherwise appropriate for this exemption; and (D) is not intended for testing donors, donations, or recipients of blood, blood components, human cells, tissues, cellular-based products, or tissue-based products. (2) High-risk test limitation or condition A high-risk test may be exempt under paragraph (1) from the requirements of this subchapter only if— (A) no components or parts of such test, including any reagent, is introduced into interstate commerce under the exemption under subsection (e), and any article for taking or deriving specimens from the human body used in conjunction with the test remains subject to the requirements of this subchapter; or (B) the test has been developed in accordance with the applicable test design and quality requirements under section 587K. (c) Public health surveillance activities (1) In general The provisions of this subchapter shall not apply to a test intended by the developer to be used solely for public health surveillance activities. (2) Exclusion An in vitro clinical test used for public health surveillance activities is not excluded from the provisions of this subchapter pursuant to this subsection if such test is intended for use in making clinical decisions for individual patients. (d) General laboratory equipment As set forth in section 201(ss)(3)(C), general purposes laboratory equipment is not an in vitro clinical tests and is not subject to the requirements of this subchapter. (e) Components and Parts (1) In general Subject to paragraph (2), a component or part described in section 201(ss)(2)(G) is— (A) exempt from the requirements of this subchapter if it is intended for further development as described in paragraph (3)