The report also noted that the commissioner showed "unusual interest in the composition of the panel," asking to see their resumes, and "pressed the Center to issue a decision" shortly after the panel's November meeting, as did the company.
The center's staff had initially determined that Menaflex was not substantially equivalent to existing approved devices and hence ineligible for 510(k) approval. But Schultz ordered a reconsideration of that determination, which was subsequently reversed.
Under pressure from ReGen, staff who had participated in the original negative review were not allowed to speak at the panel meeting, the investigation found.
The report also indicated that Schultz allowed the final clearance to include approval for acute as well as chronic meniscal injuries in accordance with documents submitted by the company, even though it had previously agreed to limit the requested indication to chronic injuries only.
Schultz resigned in August 2009 following allegations from some CDRH professional staff that they had been pressured by senior officials to reverse negative device evaluations.
In deciding to revoke Menaflex's clearance, the FDA also relied on input from its Orthopedic Devices Advisory Committee, which met this past March to review the scientific data on the product.
The panel expressed few concerns about the product's safety, but indicated that the evidence for its effectiveness fell short in some areas.