Regulatory compliance is critically important. However, some think product liability is just as important, if not more. Today’s guest is Mike Drues of Vascular Sciences and we discuss how companies shouldn’t fear the FDA and its regulations. Instead, they should have a healthy respect for the FDA. Who should they fear? Product liability attorneys because they can cause much more damage to a company than the FDA. Some of the highlights of the show include: ● You may not be limited to what the FDA requires. For product liability, passing FDA’s regulations isn’t enough or include everything that should’ve been done. ● When designing a product, consider product liability. Would you recommend the product to a friend or family member? Would you use it yourself? ● Product risks to consider include labeling. Does the device function normally and is it safe and effective when used according to its label? ● Manufacturers are liable when a customer doesn’t follow instructions or intended uses for the device, if they knew/should have known it could be used off label. ● Documentation is important from a regulatory/quality perspective. But for product liability, it can be the kiss of death. Be careful about what you document. ● Companies should report adverse events with a device to the FDA in a timely manner. Or, they should face regulatory and product liability consequences. ● Do you want to be proactive or reactive? Prevent issues, rather than have to correct them. Adopt a true quality culture. ● Engage regulatory guidance into the product development process early on. It’s easier, faster, and cheaper to make changes sooner than later.