We study the impact of regulating product entry and quality information requirements on an oligopoly equilibrium and consumer welfare. Product testing can reduce consumer uncertainty, but also increase entry costs and delay entry. Using variation between EU and US medical device regulations, we document patterns consistent with valuable learning from more stringent US requirements. To derive welfare implications, we pair the data with a model of supply, demand, and testing regulation. US policy is indistinguishable from the policy that maximizes total surplus in our estimated model, while the European Union could benefit from more testing. " Post-market surveillance" could further increase surplus. (JEL D43, I18, L13, L51, L64, O31, O38)Most innovative new products are brought to the market because their makers believe they create new value. However, with innovation often comes uncertainty, and once in the hands of consumers, there is some chance that the product will not operate as hoped. The consequences of this failure range from consumer regret to death. When this uncertainty matters for welfare, products often must go through pre-market testing and become approved and certified by a formal body before entering the marketplace. Especially in oligopolistic markets, where private and public incentives may diverge (Spence 1975), the standard that a regulatory body imposes has the potential to fundamentally alter market outcomes by requiring testing that firms would not undertake themselves. As first highlighted by Peltzman (1973) in the context of pharmaceuticals, higher testing standards can create value through generating information that decreases uncertainty, but this benefit comes with the potential cost of fewer available products due to delayed entry and higher entry costs from more testing. Today such certification processes are commonplace