FDA guidance document ``Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications"+

Federal Register: Guidance for Industry and Food and Drug Administration Staff; Factors To Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and de Novo Classifications; Availability

at Food and Drug Adminstration (FDA): CDRHNew - 2 hours ago

The FDA is announcing the availability of the guidance document "Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications" This guidance is intended to provide greater... more »