; (2) conduct and submit the results of any studies required under subsection (b)(3); and (3) make any labeling change described in subsection (c) by the date specified by the Secretary pursuant to such subsection. (b) Notification (1) In general The Secretary may issue an order requiring the manufacturer of any essential device to submit, in such manner as the Secretary may prescribe, data and information from any stage of development of the device (including pilot, investigational, and final product validation) that are adequate to assess the shelf life of the device to determine the longest supported expiration date. (2) Unavailable or insufficient data and information If the data and information referred to in paragraph (1) are not available or are insufficient, the Secretary may require the manufacturer of the device to— (A) conduct studies adequate to provide the data and information