Direct from FDA's "egg on our face" department comes the confession of press officer Karen Riley that she mislaid the answer to our request for clarification about the agency's jurisdiction/no jurisdiction over "restricted" device advertising, thus missing our deadline. Our story, CDRH Disowns Statutory Authority Over LASIK Ads, attempted to reconcile a 20-month-old CDRH letter to eye care professionals asserting FDA jurisdiction over their LASIK ads with a 1/29 statement that FDA has no jurisdiction because the Federal Trade Commission has that jurisdiction.
Read more...February 2011 Archives
Twenty months after CDRH's then director of compliance, Timothy Ulatowski, cautioned the nation's eye care professionals not to make misleading or unsubstantiated claims in their advertisements about the effectiveness of lasers used in LASIK surgery, the Center has conducted no follow-up and last week announced it has no jurisdiction over LASIK ads.
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