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ReGen to FDA: 'Thanks, But No Thanks'
Date:3/22/2011

A, the agency took the unprecedented action of re-reviewing its own approval.  Dr. Jeffery Shuren, who is the Director of the Center for Devices and Radiological Health (CDRH), justified the re-review by citing a September 2009 FDA Report of which he was co-author, entitled "Review of the ReGen Menaflex: Departures from Process, Procedures, and Practices Leave the Basis for a Review Decision in Question."  

That report concludes that the original review of the device suffered from multiple internal FDA departures from processes, procedures, and practices, departures that were compounded by external pressures.  A careful reading of the report, however, reveals that within the reviewing division there was "... widespread internal disagreement and confusion about the legal standard for 510(k) review."  It also states that "OCC [FDA's legal division] advised that review of a 510(k) involves a comparison of a device to a predicate rather than to a standard of care and that there was no legal foundation for requiring a company to demonstrate clinical benefit in a 510(k). This interpretation supported ReGen's long-standing argument that the Center was holding the CS device to the wrong review standard."

In March 2010, ReGen sent a letter to FDA Commissioner Hamburg regarding this report.  That 66-page letter provided a detailed analysis stating that the report "...contains inaccuracies, misrepresentations, speculation, and bias, and omits material information... The extent and depth of these irregularities raise the question of whether the preliminary report was intended to discuss the results of the agency's internal investigation or instead provide support for a foregone conclusion, i.e., a re-examination of the Menaflex device 510(k) clearance."  Commissioner Hamburg has yet to even respond to a request in this letter to correct or retract the errors in the report as required by law.

The "re-review" took almost one ful
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SOURCE ReGen Biologics, Inc.
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