FDA Releases Guidance on Premarket Approval Applications

Summary

The Food and Drug Administration (FDA) has made available a new guidance document clarifying the criteria for accepting and filing Premarket Approval Applications (PMAs), aiming to ensure consistency in the agency's decisions on these applications, primarily for original PMAs and PMA panel-track supplements reviewed by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER).