a high-risk or moderate-risk in vitro clinical test to conduct postmarket surveillance of such in vitro clinical test, if the failure of the in vitro clinical test is reasonably likely to result in serious adverse health consequences or death from use of such in vitro clinical test. (2) Consideration In determining whether to require a developer to conduct postmarket surveillance of an in vitro clinical test, the Secretary shall take into consideration the benefits and risks for the patient and the least burdensome requirements under section 587AA(c). (b) Surveillance approval (1) In general Each developer required to conduct surveillance of an in vitro clinical test shall submit, within 30 days of receiving an order from the Secretary, a plan for the required surveillance. The Secretary, within 60 days of the receipt of such plan, shall determine if the person designated to conduct the surveillance has the appropriate qualifications and experience to undertake such surveillance and if the plan will result in useful data that can reveal unforeseen adverse events or other information necessary to protect the health of patients or the public. (2) Timeline The developer shall commence surveillance under this section not later than 15 months after the day on which the Secretary orders such postmarket surveillance, unless the Secretary determines more time is needed to commence surveillance. (3) Prospective surveillance The Secretary may order a prospective surveillance period of up to 3 years. Any determination by the Secretary that a longer period is necessary shall be made by mutual agreement between the Secretary and the developer or, if no agreement can be reached, upon the completion of a dispute resolution process pursuant to section 562. 587Y. Electronic format for submissions (a) In general All submissions to the Food and Drug Administration with respect to an in vitro clinical test, unless otherwise agreed to by the Secretary, shall— (1) be made electronically