We acknowledge that you have destroyed key components of the _____ and thus have terminated your _____ of this device. Please advise this office, in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to prevent recurrence in future _____ of violations similar to those listed above. For your information, copies of 21 CFR Parts _____ and _____ are enclosed. Your response should include a certification that you will not use the _____ components you did not destroy, mainly the computer used to operate the _____, along with its _____ algorithms and software data base, in the assembly of a _____ to treat patients, unless an approved _____ or _____ is in effect for the resulting device. Please send your response to the Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Division of Bioresearch Monitoring, Program Enforcement Branch II (HFZ-312), 2098 Gaither Road, Rockville, Maryland 20850, Attention: Jean Toth-Allen, Ph.D.
