Moreover, FDA said that the testing data for the Celution
were based on a study of only 12 donors and thus not
sufficient to demonstrate substantial equivalence. Therefore,
FDA concluded that Cytori’s devices would need to complete
the more extensive premarket approval process.
Cytori contests FDA’s “not substantially equivalent”
determination. Cytori claims that the Celution and the
StemSource share an intended use with other predicate
devices already on the market: They all process tissue
samples and isolate cells. In addition, according to Cytori,
the devices share basic technological characteristics. Cytori
therefore claims that FDA acted unreasonably in rejecting its
FDA contends that this Court does not have jurisdiction
to hear Cytori’s petitions and, alternatively, defends its
determination on the merits.
As a preliminary matter, FDA asserts that this Court lacks
jurisdiction to hear Cytori’s petitions. In particular, FDA
argues that the relevant statutes establish the district court as
the proper forum for initial review of Cytori’s petitions.
In general, initial review “occurs at the appellate level
only when a direct-review statute specifically gives the court
of appeals subject-matter jurisdiction to directly review
agency action.” Watts v. SEC, 482 F.3d 501, 505 (D.C. Cir.
2007). The medical device section of the Food, Drug, and
Cosmetic Act contains such a direct-review provision. See
cells – those cells could foreseeably be used for treatment at a later