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Home » Final Pivotal Trial Guidance Addresses Unblinded Device Studies
Final Pivotal Trial Guidance Addresses Unblinded Device Studies
November 8, 2013
The FDA strongly recommends blinding in device pivotal trials, when possible, and notes that, even if the subject and/or the investigator cannot be blinded, devicemakers may be able to secure a blinded third-party evaluator to assess the study endpoints.