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Start Over Subjects Device Approval -- standards ✖Remove constraint Subjects: Device Approval -- standards Titles Consideration of uncertainty in making benefit-risk determinations in medical device premarket approvals, de novo classifications, and humanitarian device exemptions: guidance for industry and Food and Drug Administration staff ✖Remove constraint Titles: Consideration of uncertainty in making benefit-risk determinations in medical device premarket approvals, de novo classifications, and humanitarian device exemptions: guidance for industry and Food and Drug Administration staff Dates by Range 2000 and later ✖Remove constraint Dates by Range: 2000 and later

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  • Consideration of uncertainty in making benefit-risk determinations in medical device premarket approvals, de novo classifications, and humanitarian device exemptions: guidance for industry and Food and Drug Administration staff1