Why Attend?
If you have a case involving medical devices, you need this seminar!
- Explore the FDA powers over medical devices
- Understand the procedures it uses, and the documentation it produces
- Learn how such documentation can affect your medical device case
Medical devices are very broadly defined by the applicable law. The definition includes everything from basic products such as bandages up to and even beyond the latest sophisticated surgical implants. These products are used in almost all aspects of modern medicine, often enabling positive outcomes once thought impossible.
On occasion, however, an outcome is not so positive, whether through errors of design, labeling, or manufacture. This can be the basis for personal injury litigation. Can the U.S. Food and Drug Administration (FDA) regulatory actions impact this litigation? Beyond those concerns, knowledge of the FDA’s regulation of medical devices will enhance a lawyer’s ability to assist a company that makes or markets such products.
The FDA has plenary authority over medical devices, regulating how they are made, marketed, and sold, always with an eye toward effectiveness and safety. The rigor of the approval process depends on the FDA’s assessment of the risk the device poses. Those with the greatest risk receive the greatest scrutiny. Once medical devices are in the market, the FDA is tasked with monitoring the safe manufacture through a series of quality system regulations and inspections. In all of these functions the agency has a wide array of enforcement powers including but not limited to issuing inspection reports, warning letters, as well as requiring product recalls, and, where the agency deems needed, enforcement through civil and even criminal prosecution.
Our speakers, whose expertise involves years of working closely with, and against, the FDA in its regulatory role, will distill the FDA’s process to its essentials, and present it in an understandable and useful manner.
Can the FDA and its actions be a source of evidence for a case you are planning to bring or to defend? If so, having an understanding of FDA procedures will help your case preparation and execution. A better understanding of FDA regulatory authority means a lawyer can better advise a medical device client.
If you want to or need to know something about the FDA, these two hours will be a good investment of your time.