11

Jul

2001

Paul E. Garland M.D.

0

Company: Paul E. Garland M.D.
Date: 7/11/01
Product: Excimer Laser

Medical devices used by doctors in their course of their practice to treat patients are “marketed” and “held for sale” within the meaning of the Federal Food, Drug and Cosmetic Act (the Act). An excimer laser is a class III device under section 513(f) of the Act, and as such it is adulterated under section 501(f)(1)(B) of the Act unless there is a PMA or an investigational device exemption (IDE) in effect for it. Although your laser (50065) has a long working distance arm installed by Nidek Co., Ltd. while it was in Canada, this laser still contains software version 2.25dhc, which is an _____ version, not approved for commercial distribution in the United States. This laser does not meet all of the specifications for approval of Nidek’s PMA for the EC-5000 excimer laser and is not considered to be covered by that PMA. Because an approved PMA or an approved IDE does not cover this laser, it is adulterated within the meaning of the Act. Therefore, you should not be using this laser to treat patients.

FDA District: Denver

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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