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AdvaMed Comments on Docket No. FDA-2018-D-3130: Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions; Draft Guidance for Industry and Food

Comments

AdvaMed Comments on Docket No. FDA-2018-D-3130: Consideration of Uncertainty in Making 
Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo 
Classifications, and Humanitarian Device Exemptions; Draft Guidance for Industry 
and Food and Drug Administration Staff 

application/pdf - 2.37 MB
Date:
11/16/2018
Issues: