04

Nov

1997

Natural Sight Vision Center

0

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.

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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