On March 27, 2012, the Food and Drug Administration ("FDA") issued informal guidance illustrating considerations made during FDA's per-market review process, including a set of risks and benefits weighed by the agency. FDA's guidance "outlines the systematic approach FDA device reviewers take when making benefit-risk determinations during the premarket review process." FDA's guidance is intended to serve as a "tool that explains the various principal factors considered by the agency during the review of PMA applications, the regulatory pathway for high-risk medical devices, and de novo petitions, a regulatory pathway available for novel, low- to moderate-risk devices." FDA's approach in issuing this guidance "takes into account patients' tolerance for risks and perspectives on benefits, as well as the novelty of the device."
More information on FDA's guidance is available here. A copy of FDA's guidance is available here. Mark Faccenda