Guidance for Industry and FDA Staff: Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications
This guidance document was developed to identify and clarify the factors FDA considers when making benefit-risk assessments in premarket approval, or PMA applications, and de novo classification petitions for medical devices. FDA believes that the full implementation of the guiding factors described in this guidance will facilitate transparency, consistency, and predictability of the premarket benefit-risk assessment process.
This guidance document was published in its final form on March 27, 2012. It will apply to all premarket approval and de novo classification decisions made beginning May 1, 2012