New FDA Guidance for Benefit-Risk Determinations in PMA Application of Medical Device Classification

This non-binding guidance published on March 28, 2012 is applicable to devices subject to premarket approval (PMA) applications or de novo classification petitions. It explains the principal factor that FDA considers when making benefit-risk determinations in the premarket review of certain medical devices which includes both diagnostic and therapeutic devices. The benefit-risk factors apply to all stages of medical device development including pre-Investigational Device Exemption (IDE) and IDE phases. 
FDA Guidance: Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications