Mike advises manufacturers, health care providers, developers, and investors on the legal, regulatory, and reimbursement issues that arise during the development and commercialization of medical devices, drugs, biological products, and clinical laboratory testing services. Mike advises clients on the regulatory issues that arise throughout the life cycle of FDA-regulated medical devices, drugs, and biological products. He is particularly experienced in the review of promotional/marketing materials for FDA-regulated medical products, as well as the FDA’s evolving requirements for mHealth products, including mobile medical applications and clinical decision support software. Mike regularly counsels clinical laboratories on federal (CLIA) and state regulatory issues, as well as the FDA’s ongoing efforts to regulate laboratory-developed tests (LDTs). Mike also helps clients develop and implement strategies to persuade Medicare, Medicaid, and other third-party payers to establish adequate coverage and reimbursement for their products and/or the services in which their products are utilized. Mike is a member of the American Health Lawyers Association and the Food and Drug Law Institute. Mike is admitted to practice in Maryland and the District of Columbia. Attorney Advertising. Prior results do not guarantee a similar outcome.