Recipient: William Gray M.D. – Swedish Medical Center
Product: Investigational devices
Date: 3/16/05
In response your written response, you claim that investigators will continue to work with management and staff to assure protocol adherence. Also, the department has installed new software that provides a check-list for study protocol required procedures. This change should assist you in ensuring study procedures are completed as outlined by the protocol.
Issuer: Center for Devices and Radiological Health (CDRH)