Temporary Deferment of Activities Relating to Medical Device Submissions

概要

The Food and Drug Administration (FDA) is announcing that the Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) has completed the move from its former Rockville, MD, location to its new location in that same city. FDA is announcing that during the period required for the move, from October 7, 1994, through October 21, 1994 (14 calendar days), the agency continued to accept mail, but did not officially receive premarket notifications, premarket approval applications, or investigational device exemption applications, nor continue its review of such pending submissions. The statutory review periods on pending submissions were suspended during this 14-day period needed for the relocation of ODE. The new address for submissions to ODE is set forth below.