Nov

1997

The Center for Corrective Eye Surgery

The Food and Drug Administration (FDA) inspected your medical practice on September 3, 4 and 15, 1997, and determined that you are using an unapproved excimer laser system assembled by _____ an engineering consultant with _____ and representatives of _____ This laser system contains software developed by _____ with your input into its design. This excimer laser system is a device within the meaning of section 201(h) of the Federal Food, Drug and Cosmetic Act (the Act). Excimer laser systems are Class III devices which are required to have in effect an approved application for premarket approval (PMA) or an approved Investigational Device Exemption (IDE).

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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The Center for Corrective Eye Surgery

Amy Sellers

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