DEVICE MANUFACTURERS: Worried about the FDA crackdown on third-party suppliers? Uncertain how to respond? Seeking guidance? Worry not … Washington is coming to YOU!

The FDA and Justice Department attorneys are warning that they are considering pushing strict liability cases harder to get device executives to accept responsibility for their supply chains, “sister facilities” and just plain rogue suppliers.

This focus on corporate responsibility is only in its nascent stages. It’s going to get worse. Some lawyers think the FDA will almost certainly require more specific record-keeping for supply-chain issues, including third-party certification requirements all the way up the line to final manufacturing. Will this be another Sarbanes-Oxley regulation nightmare?

We’re responding to these issues on your behalf the best way we know how — by inviting top FDA officials and elite industry experts to speak directly to you. No need to worry about travel costs or time out of the office. We’ll bring this intelligence briefing directly to your conference room.