FDAnews Device Daily Bulletin

FDA WARNS INVESTIGATOR FOR USING UNAPPROVED DEVICE IN STUDY

March 9, 2007
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The FDA warned an investigator for changing devices he used in a clinical study without approval.

The agency found during inspections Aug. 30Sept. 11, 2006, that Robert Ritch at the New York Eye and Ear Infirmary used a different device than specified in the study protocol, the Dec. 4, 2006, warning letter said. Ritch and another physician conducting the study used the different device to treat at least eight of the study's 16 subjects, according to the FDA.

Using a different device violates the conditions of the study's institutional review board (IRB) approval, according to the letter, posted to the agency's website recently. Ritch did not request approval from the sponsor, the IRB or the FDA before using the new device, the letter added.

The warning letter can be viewed at www.fda.gov/foi/warning_letters/g6155d.pdf ( http://www.fda.gov/foi/warning_letters/g6155d.pdf ).

( http://www.fdanews.com/ddl/34_10/ )