; or (2) present an imminent threat to public health. (c) Submission of quarterly reports As applicable, a developer shall submit quarterly reports that include any in vitro clinical test errors and serious injuries that occurred during the applicable quarter. Such quarterly reports shall be submitted not later than the end of the quarter following the quarter in which the developer receives or becomes aware of such adverse events. (d) Definitions For the purposes of this section— (1) the term in vitro clinical test error means a failure of an in vitro clinical test to meet its performance specifications, or to otherwise perform as intended by the developer, including an inaccurate result resulting from such failure; and (2) the term serious injury means— (A) a significant delay in a diagnosis that results in the absence, delay, or discontinuation of critical medical treatment or that irreversibly or seriously and negatively alters the course of a disease or condition; or (B) an injury that— (i) is life threatening; (ii) results in permanent impairment of a body function or permanent damage to a body structure; or (iii) necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure. (e) Regulations The Secretary shall promulgate regulations to implement this section. 587N. Corrections and removals (a) Regulations The Secretary shall promulgate regulations, or amend existing regulations, as appropriate, to implement this section. (b) Reports of corrections and removals (1) In general Each in vitro clinical test developer shall report to the Secretary any correction or removal of an in vitro clinical test undertaken by such developer if the correction or removal was undertaken— (A) to reduce the risk to health posed by the in vitro clinical test