CDRH will reevaluate its 510(k) clearance decision on ReGen Biologics’ controversial
Menaflex Collagen Scaffold (CS) because the original review process was compromised, according to a just-released preliminary report that investigated the Center’s decision not to require a PMA submission for the device. The
internal review was ordered (see story) in May by FDA principal deputy commissioner Josh Sharfstein after Senate Finance Committee ranking
member Charles Grassley (R-IA) raised questions about CDRH’s actions involving the device. At the time, Sharfstein said
that Grassley’s "questions and the controversy surrounding this matter raise legitimate concerns about whether
the agency’s review process and decision to clear for marketing the ReGen Collagen Scaffold were compromised."
The findings from the Menaflex investigation led the agency 9/23 to authorize an independent review by the Institute
of Medicine on whether it’s time to revamp the entire 510(k) process (see story).
"Troubling questions that remain about the clearance
decision and its effect on future 510(k) reviews warrant an independent science-based reevaluation of the CS device SE decision,"
the report says. "The reevaluation should consider the decision to permit review of the device in a 510(k) submission."
If this reevaluation supports review of the CS device in a 510(k) submission, the reevalution should assess whether the file
for k082079 provides an adequate basis for the SE decision." The reevaluation, according to the report, will examine:
(i) the basis for the decision
that the mesh is intended to repair and reinforce rather than replace tissue;
(ii) whether appropriate predicates exist for a surgical mesh for use in an intra-articular space; and
(iii) what type of data are necessary and may be required in relation to the intended use and application type.
The Menaflex clearance had been controversial amid allegations that four New Jersey lawmakers — Rep. Frank
Pallone (D-NJ), Rep. Steve Rothman (D-NJ), Sen. Robert Menendez (D-NJ), and Sen. Frank Lautenberg (D-NJ) — intervened
on the company's behalf to move the device’s review through FDA (see earlier story). Additionally, based on these lawmakers efforts, then-FDA commissioner Andrew von Eschenbach directed
agency staff to allow the company to have input into the "structure and composition" of an advisory committee that
reviewed the device....
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