; or (2) as evidence of the entity’s intent to market the product for an indication or use for which the product has not been approved or cleared by the Secretary. (g) Identification of essential devices (1) In general In the event of, or in advance of, a declaration of a public health emergency pursuant to section 319 of the Public Health Service Act, the Secretary shall designate and make publicly available, including on the public website of the Food and Drug Administration, a list of devices that are critical to preventing, screening, diagnosing, treating, or mitigating the spread of a disease or condition during such emergency. (2) Consideration In developing such list, the Secretary shall take into consideration— (A) the medical necessity of devices; (B) the urgency to prevent serious injury or death; and (C) the availability of other devices. (3) Updates During the course of such public health emergency, the Secretary shall update the list of essential devices as necessary, including adding and removing devices. (h) Definitions For purposes of this section: (1) Essential device The term essential device means a device designated in a list in effect under subsection (g). (2) Manufacturer The term manufacturer means the entity that holds the medical device marketing submission, or if a medical device marketing submission is not required, the entity responsible for listing the medical device under section 510. (3) Meaningful disruption The term meaningful disruption — (A) means a change in production that is reasonably likely to lead to a reduction in the supply of an essential device that is more than negligible and affects the ability to fill orders or meet expected demand for the device of the manufacturer or contract terminal sterilizer involved; and (B) does not include, so long as the manufacturer expects to resume operations in a short period of time, not to exceed 6 months, interruptions in— (i) manufacturing due to matters such as routine maintenance or insignificant changes