Last month, the United States Court of Appeals for the District of Columbia Circuit ruled in favor of the FDA in denying the clearance of Cytori’s Celution 700 and StemSource 900. See Opinion Cytori Therapeutics, Inc. vs. FDA, 11-1268, 2013 WL 1164775 (D.C. Cir. March 22, 2013). There are two key observations in this ruling. First, Court of Appeals for the District of Columbia Circuit is a proper forum to directly challenge FDA’s final determinations on premarket device applications. Second, such Court defers to FDA’s scientific judgment on questions challenging FDA’s decision on safety and effectiveness of a medical device.
By the way of background, Cytori, choosing the preapproval notification regulatory path, filed two 510(k) applications for two cell harvesting devices. One version for harvesting and preparing stem cells for clinical laboratory analysis. The other intended to harvest stem cells but for storage. Cytori claimed that the devices were substantially equivalent to currently marketed devices that harvest cells from blood and bone marrow. FDA denied substantial equivalency on the basis that "fat is not blood" and that the use of a certain enzyme that is used to separate the useful cells from other tissue can pose new safety questions based on its effect on the harvested cells. FDA concluded that Cytori’s devices would need to complete the more extensive premarket approval process.
At the Appeal level, Cytori alleged that the FDA acted unreasonably in rejecting Cytori’s applications and further mandating that Cytori’s devices undergo the premarket approval process. FDA, on the other hand, challenged the jurisdiction of the Court asserting that the district court is the proper forum for the initial review of the issue. FDA added that relevant statute only provides for review of an affirmative order at the Court of Appeals level.
The Court disagreed with the FDA and observed that the 21 U.S.C. §360g(a) allows that “any person adversely affected by a specified regulation or order to file a petition in the U.S. Court of Appeals for the D.C. Circuit.” An “order” under APA is defined as “the whole or a part of a final disposition, whether affirmative, negative, injunctive or declaratory in form” 5 U.S.C. §551(6). Thus, any final non-equivalence determination, even if negative in nature is an “order” from the FDA and reviewable by the Court of Appeals.
On the question of substantial equivalency, the Court deferred to the FDA’s scientific judgment. under 21 U.S.C. § 360c(i), a device must meet two core criteria to be substantially equivalent to a currently marketed device. First, the device must have “the same intended use as the predicate device.” 21 U.S.C. § 360c(i)(1)(A). Second, the new device must also have “the same technological characteristics as the predicate device” or, if not, the submitted data must establish that the new device is both equally “safe and effective as a legally marketed device” and “does not raise different questions of safety and effectiveness than the predicate device.” Id.
The Court in Cytori expressed that it “is ill-equipped to second-guess that kind of agency scientific judgment under the guise of the APA’s arbitrary and capricious standards.” Thus, as long as FDA’s act appears reasonable, the Court would not likely challenge the FDA’s authority on interpreting the scientific evidence related to safety and effectiveness of a product.
In short, you may be able to take FDA’s negative determination of substantial equivalency directly to the Court of Appeals for the District of Columbia, but you may not find sympathy in challenging FDA’s scientific judgment.