FDA publishes a final guidance to assist sponsors in submitting human factors information with medical device marketing applications to fit the FDA risk-based framework.
FDA publishes two final guidances on aspects of establishing bioequivalence.
FDA publishes a final guidance to assist sponsors in submitting human factors information with medical device marketing applications to fit the FDA risk-based framework.
FDA publishes two final guidances on aspects of establishing bioequivalence.
Reps. Debbie Dingell and Rich McCormick say FDA should update its strategy for evaluating and identifying sepsis as a means to exclude inappropriate tissue donors.
FDA marks the 50th anniversary of the 1976 Medical Device Amendments by highlighting the law’s lasting role in shaping the modern oversight of medical devices.
