If you are appearing before the FDA and its counterpart authorities abroad, we can provide you with counsel on all phases of the product development cycle, including pre-clinical activities, clinical trials, the application process, and the post-market environment. We have experience with the design process and the failure analysis, verification, or validation protocols, as well as the necessary reports needed to produce medical devices. We also have been intricately involved in representing sponsors, public and private institutions, IRBs, clinical research organizations (CROs), site management organizations (SMOs), and principal investigators on a variety of complex matters involving clinical research.
Our attorneys can advise you on device clearance and approval strategies, including 510(k) strategies, product classification, and reclassification. We also offer counseling on IDE requirements, clinical trial issues, and humanitarian device requirements. To help you reach patients as quickly as possible, we can develop regulatory strategies such as fast track, accelerated approval, and treatment IDEs to bring your new products to market. We can provide counsel throughout the application process, including leading FDA meetings and appeals.