decision by the Secretary to change a regulatory pathway designation, or reclassifies an in vitro clinical test, or category of in vitro clinical tests, the Secretary shall provide an appropriate transition period with respect to any new requirements. (c) Appeals A decision by the Secretary under this section shall be deemed a significant decision subject to appeal under section 587P. (d) Advisory committee The Secretary may request recommendations from an advisory committee under section 587H pursuant to carrying out this section. (e) Request for informal feedback Before submitting a premarket application or technology certification application for an in vitro clinical test— (1) the developer of the test may submit to the Secretary a written request for a meeting, conference, or written feedback to discuss and provide information relating to the regulation of such in vitro clinical test which may include— (A) the submission process and the type and amount of evidence expected to demonstrate the applicable standard