Draft Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review for Premarket Approval Applications; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Acceptance and Filing Review for Premarket Approval Applications (PMAs)." The purpose of the acceptance and filing reviews is to make a threshold determination about whether an application is administratively complete. This guidance document is intended to clarify the criteria for accepting and filing a PMA, thereby assuring the consistency of our acceptance and filing decisions. This guidance is applicable to original PMAs and PMA panel-track supplements reviewed in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research. This draft guidance is not final nor is it in effect at this time.