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:
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:
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.