; (B) a specimen receptacle; (C) an in vitro clinical test that is moderate-risk; or (D) an in vitro clinical test that is determined by the Secretary to be eligible for abbreviated premarket review under section 587F(a)(1)(B). (2) Application content An application under paragraph (1) shall include— (A) the information required for applications submitted under subsection (a)(3), except that applications under paragraph (1) need not include— (i) quality requirement information; or (ii) raw data, unless requested in writing by the Secretary, in accordance with the least burdensome requirements under section 587AA(c), and with supervisory review and concurrence prior to issuance of such request; and (B) data, as applicable, to support software validation, electromagnetic compatibility, and electrical safety, and information demonstrating compliance with maintaining quality systems documentation. (3) Safety information The developer of an in vitro clinical test specimen receptacle reviewed under this subsection shall maintain safety information for such specimen receptacle. (4) Inspections With respect to an application under paragraph (1), preapproval inspections shall not be required unless requested in writing by the Secretary, after supervisory review and concurrence, because such inspection is considered necessary to complete the review. (c) Instruments and instrument families (1) In general A developer of an instrument family shall file with the Secretary an application for premarket approval of one version of an instrument under this subsection. Any modified versions of the instrument that generate a new instrument within the same instrument family shall be exempt from premarket review requirements of this section, provided that the developer of such instrument or instrument family— (A) maintains documentation that the new instrument is part of the instrument family, as defined in section 587