510(k) vs. PMA — Making the Right Choice for Your Corporate Strategy: Will Congress Kill Preemption Protections for PMA-Approved Devices?

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Deciding whether filing a 510(k) or a PMA is the best risk management strategy for your device was a tough decision before. Now another layer has been added as you weigh your choices.

A devicemaker spends an average of 20 hours on a 510(k) filing. Premarketing approval (PMA) takes 1,200 hours or more and includes rigorous approval requirements, postapproval reporting, sales restrictions and strict change control. Sounds like an easy decision, but making a choice between a 510(k) and a PMA just isn't that simple ...

If the proposed legislation passes, devices that are approved under a PMA may or may not be considered "preempted", and may or may not be subject to many product liability lawsuits filed in state courts. Meanwhile, devices that receive 510(k) clearance, however, are subject to those lawsuits.

So, how can you decide which is best for your device?

Noted attorney Stephen A. Wood, a partner with Kelley Drye walks you through the latest developments in the courts and Congress. Plus, in this 90-minute Encore presentation he offers professional guidance on these two choices for your device approval and how they fit into your risk management plan.  He’ll also:

  • Describe the meaning and scope of preemption as defined by the watershed U.S. Supreme Court case Medtronic, Inc. v. Lohr (1996)
  • Examine the patchwork of cases that followed in circuit courts which allowed PMA-approved devices to stay out of state courts in most cases
  • Demonstrate, in detail, when a PMA-approved device can stay out of state court and when it can’t
  • Show the benefits and risks to filing a 510(k), and whether it makes sense to make changes to your device and pursue a PMA or roll the dice with a 510(k)

Sign up your entire team to listen in and discover:

  • The latest legislative updates to the proposed Medical Device Safety Act of 2008
  • A clear understanding of what preemption can mean for a device
  • The claims that preemption protects against, and those it does not
  • The process for gaining preemption — many factors are involved (including where in the U.S. a lawsuit is filed)
  • The current and future trends of the 13 U.S. Circuit Courts and Supreme Court  — where the courts are headed regarding preemption
  • The FDA’s viewpoint on preemption in general and devices in particular
  • The risks and benefits of PMA versus 510(k) options for devicemakers in light of the preemption doctrine 

Register now and gain the knowledge you need to decide whether filing a 510(k) or PMA is the best choice for your risk management strategy — and how to deal with the consequences of each! Plus, you’ll get an opportunity to ask your toughest questions during the Q&A session.

This presentation is a must for positions in the medical device industry, including:

  • Compliance officers
  • Consultants/service providers
  • Executive management
  • General/corporate counsel
  • Managers
  • Regulatory/legislative affairs professionals
  • Risk management specialists
  • Strategic planning and business development staff
  • Outside attorneys

Stephen A. Wood, partner with Kelley Drye, has represented numerous medical device firms on cases involving laparoscopic surgical devices, interventional cardiovascular devices and breast implants, among others. He has first- or second-chaired more than a dozen trials of major cases ($1,000,000+ damages sought) over the past ten years. He has first chaired jury trials in both state and federal courts.

Stephen has argued appeals twice before the Illinois Appellate Courts and won both appeals. He has been involved on the brief in several other appeals, and he appears as counsel of record in several reported decisions. Stephen has experience as both regional counsel and national counsel for Fortune 500 companies in recurrent products litigation. He also has served as defense liaison counsel in statewide coordinated products litigation and has extensive experience in multidistrict litigation.

Stephen has spoken at numerous medical device industry events and has been published in legal journals. He received his JD cum laude from the Loyola University of Chicago.

Register now!

Date: Sept. 29 – Oct. 17, 2008
Location: Your office or conference room (no need to travel!)
Time: Anytime

Gather your team for maximum benefit! Your investment is for one dial-in.

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