In the United States, the Food and Drug Administration (FDA) has control over which medical devices shall be authorized on the market, this includes premarket approval, registration and listing, requirements for production using proper manufacturing practices and requirements for post-market reporting of device failures. Paul Kramsky, former Vice-President and Global Regulatory Affairs of Bausch & Lomb and current President of Rockin’ Regulatory, gives a step-by-step explanation on how to obtain medical device clearance on the US market.

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