This post was written by Erin Janssen.

On August 13, 2012, FDA released draft guidance for public comment entitled “Refuse to Accept Policy for 510(k)s.” The purpose of this document is to explain the procedures and criteria FDA intends to use in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 premarket notification (510(k)) submission is administratively complete, which determines whether it should be accepted for substantive review. The guidance is applicable to 510(k)s reviewed by the Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research. To ensure that comments are considered before the agency begins work on the final version of the guidance, interested parties should submit comments on the draft guidance by September 27, 2012.