The FDA has published guidance for medical device manufacturers that describes how the benefits and risks of certain medical devices are considered during pre-market review.  Specifically, the guidance: (i) outlines the systematic approach FDA device reviewers take when making benefit-risk determinations during the premarket review process; (ii) provides manufacturers a tool that explains the various principal factors considered by the agency during the review of premarket approval applications, the regulatory pathway for high-risk medical devices, and de novo petitions; and (iii) describes an approach that takes into account patients’ tolerance for risks and perspectives on benefits, as well as the novelty of the device. The guidance applies to both diagnostic and therapeutic devices. The guidance includes a worksheet for device reviewers that incorporates the principal factors that influence benefit-risk determinations, such as the type, magnitude and duration of a risk or benefit, the probability that a patient will experience the risk, patient tolerance for risk, availability of alternative treatments, and the value the patient places on treatment.