Terms. 1  mesencephalon A part of the brain located rostral to the pons and caudal to the thalamus and the basal ganglia, composed of the tectum (dorsal portion) and the tegmentum (ventral portion). 2  substantia nigra Brain structure located in the midbrain that plays an important role in reward and movement.
De novo review refers to the appellate court's authority to review the trial court's conclusions on questions of the application, interpretation, and construction of law. Generally, the proper standard of review for employee benefit decisions, such as the denial of benefit claims, is de novo.
The 510(k) process allows for a 90 day review period while the de novo process has a 120 day review cycle. In 2011, the FDA released a draft guidance document proposing to allow sponsors to simultaneously submit 510(k) and de novo submissions, thus eliminating the sequential portion of the process.