Regulatory complianceRegulatory compliance is focused on bringing a safe and effective medical device product to market. Regulatory complianceRegulatory compliance involves more than merely submitting a 510(k), De Novo, or PMA to the FDA for clearance, grant, or approval. Rather, regulatory complianceRegulatory compliance involves the thoughtful planning, development and implementation of a medical device regulatory strategyRegulatory strategy. The regulatory strategyRegulatory strategy is an evaluation of the various pathways to market that are available for a medical device, and a tactical strategy (which goes hand in hand with the regulatory strategyRegulatory strategy) identifies how to go about accomplishing each step, while taking into consideration the benefits, risks, burdens and costs associated with each potential option. Regulatory strategyRegulatory strategy also involves anticipating potential problems and developing a tactical plan to address, mitigate, or avoid those problems. Each medical device product will have its own regulatory strategyRegulatory strategy and tactical plan which evolve as the medical device product transitions through development to market. The regulatory strategyRegulatory strategy starts before an FDA submission is made and lasts well into commercialization of the medical device.