510(k) vs. PMA: Making the Right Choice for Your Corporate Strategy
A devicemaker spends on average 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 ...
Devices that are approved under a PMA, are "preempted" and are not subject to many product liability lawsuits filed in state courts. Devices that receive 510(k) clearance, however, are subject to those lawsuits.
Do you know what the right choice is for your device?
In this 90-minute audio CD/transcript, noted attorneys Ivan J. Wasserman and Stephen A. Wood with Kelley Drye & Warren, offer professional guidance on these two choices for your device approval, and how they fit into your risk management plan.
In addition, they will:
- 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)
Have the facts and the clear-cut information you need to decide on 510(k) versus PMA — and how to deal with the consequences of each ...
You can listen in and discover:
- A full 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 in the future 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
Ivan J. Wasserman, partner with Kelley Drye & Warren, practices in the firm's advertising law and food and drug practice groups. He regularly represents clients before the FDA, FTC and CPSC. Ivan helps his clients develop creative approaches to meeting marketing objectives while staying within the constraints of the applicable regulatory framework. He has written articles for multiple industry publications and is a frequent and engaging speaker at industry workshops and events.
Stephen A. Wood, partner with Kelley Drye & Warren, has represented numerous medical device firms on cases involving laparoscopic surgical devices, interventional cardiovascular devices and breast implants. He has first- and second-chaired more than a dozen trials of major cases ($1,000,000+ damages sought) over the past 10 years. He has first-chaired jury trials in both state and federal courts. He has argued appeals twice before the Illinois Appellate Courts and won both appeals. Stephen has spoken at numerous medical device industry events and has been published in legal journals.