Regulatory Update

| 01 June 2010

In an effort to improve discussion and flow of information, the US Food and Drug Administration (FDA) recently announced it has changed the way its expert panels review and discuss information during public hearings on devices under review for premarket approval. In the past, panel discussions have not always reflected a panel's final vote on approvability. The changes address staffing issues, voting procedures and other items related to information presentation and flow of discussion. For example, instead of voting on the approvability of premarket applications, including conditions of approval, the panel will now vote on the safety and effectiveness of a device and its risk versus its benefit. Further, instead of a unified, consensus analysis of supporting data, reviewers will present the range of scientific opinion in the group. This change was put in effect 1 May 2010.


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