As a medical device company, your revolutionary products are built around the needs of others. In order to bring these products to the patients who need them, you require sophisticated legal counsel to help you navigate numerous industry regulations, protect your designs, and spur business growth and development. Faegre Baker Daniels partners with leading medical device companies in the U.S. and abroad to bring medical devices to market and enhance their overall business strategies.
Conforming to regulations for developing and manufacturing medical devices is a daunting task. Our professionals, including former counsel at FDA, advise on whether a 510(k) or premarket approval application (PMA) is likely to be required, whether clinical data would be required for approval or clearance, and if so, if an investigational device exemption (IDE) submission would be required. We regularly help our clients determine whether a new 510(k) is required for product changes, and then work with the client to properly document that decision. Our professionals have worked with humanitarian use devices, laboratory developed tests, companion diagnostics and the reimbursement of devices in clinical trials. We also counsel on requirements for devices regulated by the Center for Devices and Radiological Health, as well as those regulated by the Center for Biologics Evaluation and Research.
Enforcement and Litigation
We have firsthand knowledge of how to handle enforcement actions and government investigations in the medical device industry. Our professionals include two former assistant U.S. attorneys and our team has defended thousands of product liability claims. We represent medical device companies on fraud and abuse matters, including False Claims Act litigation, collateral proceedings and civil suits brought by private plaintiffs. Our professionals help you develop a crisis communication plan and manage media interactions during disputes and investigations that could be damaging to your reputation.
We help you protect, develop, commercialize and enforce intellectual property rights. We have patented devices for nearly every system in the human body and can assist you with filing and registering patents, trademarks and domain rights in the U.S. and abroad. We have also advised on navigation of third-party patents for biologics and platform technologies.
Corporate and Transactional
We are transactional counsel to leading medical device companies, representing them in acquisitions, strategic alliances, joint ventures, supply and distribution arrangements, licensing agreements, financings, contract drafting and other matters. We can also develop templates to enhance the efficiency and autonomy of your internal procurement and other non-legal professionals.