deficient application If, after receipt of an application under this section, the Secretary determines that any portion of such application is materially deficient, the Secretary shall provide to the applicant a description of such material deficiencies and the information required to resolve such deficiencies. (7) 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 587Q need not occur unless requested by the Secretary. (b) Abbreviated premarket review (1) In general Any developer may file with the Secretary an application for abbreviated premarket approval for— (A) an instrument