Opinion ID: 768530
Heading Depth: 3
Heading Rank: 1

Heading: The Administrative Procedure Act (APA)

Text: 20 FDA decisions about adulteration and regulation are reviewed under the APA, which states that an agency's decision should not be overturned unless it was arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law. 5 U.S.C. S 706(2)(A). We have defined the arbitrary and capricious standard as follows: 21 A decision is arbitrary and capricious if the agency has relied on factors which Congress has not intended it to consider, entirely failed to consider an important aspect of the problem, offered an explana tion for its decision that runs counter to the evidence before the agency, or is so implausible that it could not be ascribed to a difference in view or product of agency expertise. 22 O'Keefe's, Inc. v. U.S. Consumer Prod. Safety Comm'n, 92 F.3d 940, 942 (9th Cir. 1996) (quoting Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983)). Most importantly, [r]eview under the arbitrary and capricious standard is narrow, and the reviewing court may not substitute its judgment for that of the agency.  Id. (citing Marsh v. Oregon Natural Resources Council, 490 U.S. 360, 376 (1989)); Presidio Golf Club v. National Park Service, 155 F.3d 1153, 1160 (9th Cir. 1998) (citations omitted). 23 In Bowen, we recently applied the arbitrary and capricious standard to a FDC Act case about whether a Class III medical device was adulterated. See Bowen, 172 F.3d at 687.  `Congress gave FDA sweeping discretion in determining the classification of devices and therefore in judging the safety and effectiveness of medical devices.'  Id. (quoting Ethicon, Inc. v. FDA, 762 F. Supp. 382, 386 (D.D.C. 1991)). In Bowen, the appellant challenged whether a machine that sterilizes dental handpieces was a device under the FDC Act's statutory definition, and whether FDA acted arbitrarily and capriciously by classifying the sterilizing machine as a Class III device subject to pre-market approval. See id. at 684. 24 In this case, Snoring Relief did not contest that SnorBan was a device pursuant to the language of the FDC Act, nor did it petition for reclassification. Snoring Relief argues that SnorBan should not be regarded as a Class III adulterated device; instead as with similar OTC [over-the-counter] antisnoring products, SnorBan should be exempt from FDA regulation. Snoring Relief claims to be exempt from FDA regulations (or be cleared for marketing) based on its pre-market notification to FDA that SnorBan is substantially equivalent to anti-snoring pillows, collars, and nasal strips. FDA repeatedly rejected these contentions. Initially, FDA compared SnorBan to other anti-snoring mouthpieces available by prescription only, concluding that a non-prescription anti-snoring mouthpiece presented new safety and effectiveness concerns about undiagnosed sleep apnea and TMJ. On two subsequentoccasions, FDA rejected Snoring Relief's comparisons of SnorBan to anti-snoring pillows, collars, and nasal strips. These agency decisions should be narrowly reviewed under the APA's arbitrary and capricious standard. Although Snoring Relief's exemption argument is slightly different than the one in Bowen, appellants in both cases are trying to avoid FDA decisions that the medical devices in question are Class III adulterated devices without pre-market approval. 25