Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for 510(k)s; Availability

Resumo

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Refuse to Accept Policy for 510(k)s." The purpose of this document is to explain the procedures and criteria FDA intends to use in determining whether a 510(k) submission is administratively complete, which determines whether it should be accepted for substantive review and clearance. This guidance is applicable to 510(k)s reviewed in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER).