Updated with response from analyst.
NEW YORK ( TheStreet) -- The chief U.S. medical device regulator did not tell Congress that rejecting Mela Sciences' (MELA) skin cancer detection device was a mistake, contrary to what a Needham & Co. analyst told his clients last week.
Needham medical technology analyst Dalton Chandler published a research report last Wednesday in which he argued that the U.S. Food and Drug Administration may be under additional pressure to approve Mela Science's MelaFind skin cancer detection device because European regulators granted the company a CE Mark, or regulatory clearance, to begin selling the device there.
In his report, Chandler writes: "The head of the CDRH, the division reviewing the MELA application, is on record in congressional testimony saying that the original 'non-approvable' letter was a mistake and should not have been sent, and if the data support MelaFind approval (and we already know it does via protocol agreement) that the device would be approved."But a review of the congressional testimony given this summer by Dr. Jeffery Shuren, director of the FDA's Center for Devices and Radiological Health (CDRH), shows that FDA's top medical device regulator said no such thing. In response to a question about the FDA's handling of the MelaFind review, Shuren responded: "The decision the first time around not to have the device go to the advisory panel was wrong. The staff made the wrong call. It should have been allowed to go to advisory panel. It eventually was. It was supported. It was a very slim margin. It was 8-7." Shuren, in his testimony, says his CDRH reviewers erred by not convening an advisory panel to review MelaFind before rejecting the device in March 2010. Shuren said nothing during his testimony about the FDA making a mistake by issuing a non-approvable letter -- FDA jargon for a rejection. "I went back and reviewed Shuren's quote and I should have worded it
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