Jan

2006

LifeScan Inc.

Recipient: LifeScan Inc.
Product: OneTouch Ultra and OneTouch UltraSmart Blood Glucose Readers

Date: 12/7/20055

Your October 6, 2005 response also describes the need to validate changes planned for your electronic complaint handling system. Again, a timeline for the completion of your validation study was not provided. The validation of your complaint handling system and the training of your employees are critical to prevent the recurrence of this observation. Without the review of your preventive action(s), it is difficult to gauge your compliance to the regulation. Upon the completion of your system validation and the training of your employees to the new complaint handling system, please provide the District Office with your documents.

FDA District: San Francisco District Office

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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LifeScan Inc.

Amy Sellers

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