1. Acceptance and filing reviews for premarket approval applications (PMAs): guidance for industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Biologics Evaluation and Research, December 16, 2019 Subject(s): Device Approval -- standardsChecklistHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
2. Refuse to accept policy for 510(k)s: guidance for industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Biologics Evaluation and Research, September 13, 2019 Subject(s): Device Approval -- standardsChecklistHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
