Opinion ID: 768530
Heading Depth: 2
Heading Rank: 3

Heading: remand to fda

Text: 32 Snoring Relief argues that at a minimum the district court erred in refusing to remand this case to FDA to consider whether a warning label about sleep apnea would be sufficient. On two prior occasions, FDA had rejected Snoring Relief's suggestions that a warning label about apnea would ameliorate the agency's safety and effectiveness concerns. A warning label about apnea ignores the concerns that SnorBan's self-fitting poses to potential sufferers of TMJ. Snoring Relief says apnea was FDA's primary concern, and TMJ was a secondary concern. This is incorrect. Both safety concerns warranted FDA's rejection of Snoring Relief's premarket notification. A remand in this case, therefore, would not be appropriate. 33 AFFIRMED.