Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
510(k) database update: Agency's device center plans to issue proposed regulations that would allow FDA to update the 510(k) database to identify the current holder of a 510(k), according to Heather Rosecrans, director of CDRH's 510(k) staff. Unlike the PMA database, the 510(k) database currently is not updated when ownership of a 510(k) is sold or transferred to another firm. The regulations "have been drafted, and I hope that very soon those will be out," said Rosecrans