FDA Drafts Guide On Using Real-World Data In Device Regulatory Decisions

July 26, 2016 at 6:54 PM
FDA issued draft guidance outlining how it plans to use real-world data to complement traditional clinical trials and support regulatory decisions for medical devices. The agency lays out a case-by-case approach for how the data can be used in a variety of pre- and post-market situations, while stressing that current evidentiary standards must still be met. The guidance comes as the device industry resists FDA's call to allocate a portion of the next round of user fees toward use of...


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