Draft Guidance for Industry and Food and Drug Administration Staff; Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review

1 organizations filed 1 public comment on Draft Guidance for Industry and Food and Drug Administration Staff; Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review, at the Food and Drug Administration. The comment window closed 5370d ago.

Abstract

Point of Contact: Rachel Turow (CDRH) & Stephen Ripley (CBER)

Commenters (1)

• Medical Imaging & Technology Alliancetrade assoc.

  1 filing · confidence 97%