The report said there wasn’t enough evidence to dispel questions about outside influence on the approval, which was granted in December 2008.
It reported “multiple departures from processes, procedures and practices” in the approval process, adding that FDA reviewers had failed to document the reasons why.
The FDA also recently announced that it is reviewing its whole rapid-approval process for medical devices, which is the route that ReGen’s device took.
Read the FDA’s preliminary report on ReGen Biologics’ Menaflex knee device (pdf).
