- A defendant’s alleged failure to obtain supplemental FDA approval of a change to a device involves an “administrative,” not a “safety” requirement. Such allegations are thus preempted “disguised fraud on the FDA” and as improper private FDCA causes of action.
- “Derivative” misbranding/adulteration claims based on the same allegations are likewise preempted.
- A defendant’s alleged failure to notify the FDA of a major change to a device in its annual report likewise involves an “administrative,” not a “safety” requirement, and is equally preempted.
- Various FDA GMP regulations (21 C.F.R. §§ 820.20, 820.80, 820.100, and 820.198) are “too generic to provide a requirement that could support a parallel claim.”
Happy holidays to all.