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) will be moving in October 1994. During the period required for relocation of files, equipment, and agency personnel, the agency will not officially receive premarket notifications, premarket approval applications (PMA's), or investigational device exemption (IDE) applications, and the agency's review of pending submissions will be delayed. The statutory review period on pending submissions will be suspended during this period needed for relocation of ODE. ODE will renew work on and will officially receive submissions after the relocation is completed. FDA estimates that the deferment period will be 7 calendar days, but it may be up to 14 days, depending on the circumstances of the move and the timing of the particular submission. Following the move, FDA will publish a notice in the Federal Register providing the new address for submissions and identifying the exact period during which action on new and existing submissions was temporarily deferred.