Introduction On June 1, FDA issued a draft guidance, Evaluation and Reporting of Age, Race and Ethnicity Data in Medical Device Clinical Studies, which provides recommendations for the evaluation and reporting of age, race, and ethnicity data in medical device clinical studies.  This draft guidance has important implications for trial…

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The Center for Devices and Radiological Health (CDRH) has followed the advice of Advisory Committees to approve or not approve a product 89% of the time. Using the resources of our firm, 3D Communications, the authors conducted a survey of current and former members of FDA Medical Device Advisory Committees to determine how they prepare and the key factors that influence their thinking.

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On April 13, 2015, FDA issued two final guidance documents on premarket approval of new medical devices. These documents represent the Agency’s current thinking on when data collection might be pushed from pre-approval to post-approval, with one guidance focused on expedited approval for devices that meet a significant unmet medical need. The following is a summary of the information provided and recommendations for Sponsors looking to take advantage of opportunities to achieve earlier and less expensive medical device approval.

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The FDA has just announced a new Draft Guidance entitled “Procedures for Meetings of the Medical Devices Advisory Committee.” Some significant procedural clarifications and modifications have been proposed that could have a broad impact on Sponsors. This article outlines key actions for Sponsors to mitigate potential risks associated with CDRH’s new approach.

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