August 14, 1997
Dr. David Dulaney Violates FDA Safety Protocols
Excerpt from FDA warning letter:"The purpose of this letter is to warn you that your [redacted] system (the [redacted] located at the Barnet Dulaney Eye Center in Mesa, Arizona, may not be used to treat patients beyond the conditions of approval of your investigational device exemption (IDE). Any use of the [redacted] beyond the terms of the FDA-approved IDE is in violation of federal law. 21. U.S.C. § 351(f)(1)(B). As discussed further below, inspection of your facility by the United States Food and Drug Administration (FDA) reveals that you have used the [] in a manner that does not comply with the Federal Food, Drug, and Cosmetic Act (the FD&C) and FDA's IDE regulations."
The complete document is available at www.usaeyes-fraud.com
Posted by Admin at August 14, 1997 11:47 PM