CYTORI THERAPEUTICS, INC. v. FOOD & DRUG ADMIN.

Nos. 11-1268, 11-1279.

715 F.3d 922 (2013)

CYTORI THERAPEUTICS, INC., Petitioner v. FOOD & DRUG ADMINISTRATION, Respondent.

United States Court of Appeals, District of Columbia Circuit.

Decided March 22, 2013.


Attorney(s) appearing for the Case

Andrew S. Ittleman argued the cause for petitioner. With him on the briefs was Mitchell Fuerst .

Adam C. Jed , Attorney, U.S. Department of Justice, argued the cause for respondent. With him on the brief were Stuart F. Delery , Acting Assistant Attorney General, and Scott R. McIntosh , Attorney. Douglas N. Letter , Attorney, entered an appearance.

Opinion for the Court filed by Circuit Judge KAVANAUGH.


KAVANAUGH, Circuit Judge:

In Administrative Procedure Act cases alleging arbitrary and capricious agency action, courts must be careful not to unduly second-guess an agency's scientific judgments. That basic principle of administrative law controls this case.

The Food and Drug Administration must approve certain medical devices before they are marketed. Here, Cytori Therapeutics applied to FDA to market two new medical devices, the Celution 700 and the StemSource...

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