FEDERAL PREEMPTION PROVISION OFFERS DEVICE FIRMS SOME LIABILITY PROTECTION
When deciding which type of FDA marketing application to submit, device firms should consider the possibility they may have to defend themselves against civil, or "tort," lawsuits if their products are linked with patient injury, legal experts told attendees at an FDAnews audioconference last month.
Firms may be better protected from potential lawsuits if they choose to file a more complex and costly premarket approval (PMA) application rather than taking the premarket notification, or 510(k), route, according to Ivan Wasserman and Stephen Wood, partners with international law firm Kelley, Drye & Warren.
By virtue of their more highly regulated nature, devices approved under PMAs are more likely to be protected by federal "preemption" -- when federal law supersedes state law.
"How a device has gotten to market will impact your legal strategy," Wood said.