Public Workshop – Using Patient Preference Information in Medical Device Regulatory Decisions: Benefit-Risk and Beyond
Posts tagged as “Benefit-Risk Determination”
GUIDELINES on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or…
Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions