; (B) a specimen receptacle; (C) an in vitro clinical test eligible for a technology certification order under section 587D; or (D) a first-of-a-kind test, unless it is a high-risk test, a direct-to-consumer test, or cross-referenced test that does not have mitigating measures. (2) Application content An application under paragraph (1) shall include— (A) the information required for applications submitted under subsection (c)(2), except that applications under paragraph (1) need not include— (i) quality requirement information; or (ii) raw data unless explicitly requested by the Secretary; (B) in the case of a specimen receptacle, safety information; and (C) data, as applicable, to support software validation, electromagnetic compatibility, and electrical safety, and information demonstrating compliance with maintaining quality systems documentation. (3) Inspections With respect to an application under paragraph (1), preapproval inspections authorized by an employee of the Food and Drug Administration or a person accredited under section 587P need not occur unless requested by the Secretary. (e) Instrument family When an in vitro clinical test has been approved, or is otherwise legally marketed, for use on a specific approved or legally marketed instrument within an instrument family, a submission under this section shall not be required for that in vitro clinical test in order for it to be used on a new instrument within that instrument’s family. (f) Amendments to an application (1) In general An applicant may amend an original or supplemental application under subsection (c) or (d). (2) Required amendment or supplement An applicant shall amend or supplement an application submitted under subsection (c) or (d) if the applicant becomes aware of information that— (A) could reasonably affect an evaluation of whether the applicable standard has been met