Medical Device News FDA news - 05-09-18 - Draft - Uncertainty in Benefit-Risk Determinations

[Marcelo]

FDA - Draft Guidance on Considering Uncertainty in Making Benefit-Risk Determinations to Support Certain Premarket Decisions for Medical Devices

https://www.fda.gov/downloads/Medic...onandGuidance/GuidanceDocuments/UCM619220.pdf