Navigating the US Regulatory Pathways

Many non-US medical device, diagnostic and pharmaceutical companies have products that would sell well in the United States, but they hesitate to enter the market. These companies market in many countries outside their home nation but don’t cross the US border.

Why avoid the largest market in the world? First, they perceive that the FDA is too tough and will cause significant difficulties and costly testing to get their products approved. Second, they are afraid of the legal system and worried that frivolous US lawsuits could put them out of business. And, third, they imagine their company would have to build a large, expensive sales force to cover the vast US market. In previous publications and webinars, we have discussed ways to reduce regulatory delays as well as costs by using experienced FDA experts and specialized filings (like the 510k or ANDA processes). Likewise, there are straight forward ways to set up separate corporate entities and obtain insurance coverage that will minimize the legal risks.

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