Full article reprinted from "The Gray Sheet" - May 18, 2009
In a sign of the intense scrutiny CDRH is facing under the new administration, FDA is taking the rare step of performing an internal review of its decision process for a recently 510(k)-cleared device. Find out more...
In a sign of the intense scrutiny CDRH is facing under the new administration, FDA is taking the rare step of performing an internal review of its decision process for a recently 510(k)-cleared device. The inquiry could potentially lead to a "reconsideration" of the clearance, the agency says.
The device is ReGen Biologics'Menaflex meniscus collagen scaffold for knee repair, cleared last December after two prior "not substantially equivalent" determinations ("The Gray Sheet" Jan. 5, 2009, p. 24).
The product, intended to facilitate new tissue growth following a knee injury, has come under significant controversy since the Wall Street Journal ran a page-one article in March reporting on a lobbying effort from the company and its congressional representatives to get the product cleared, and to influence the make-up of the advisory panel consulted by FDA.
ReGen said it was responding to reviewers who they believed were applying illegal standards to assess the firm's submissions.
Concurrently with the WSJ article, Iowa Republican Sen. Chuck Grassley sent a letter to FDA requesting information about the Menaflex review and panel meeting process.
In a letter dated May 8, FDA Acting Commissioner Joshua Sharfstein responded to Grassley with the update that a "preliminary internal review" of the Menaflex clearance process had been ordered.
- David Filmore
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