ReGen Biologics, a manufacturer of orthopedic implants, has declined the U.S. Food and Drug Administration's offer of a hearing before the agency formalizes its decision to rescind clearance of the company's Menaflex Collagen Meniscus implant, according to a company news release.
In Dec. 2008, the FDA ruled that the Menaflex Collagen Meniscus implant was as safe and effective as other surgical meshes and cleared it for use by surgeons in the U.S. Two years later, the agency called for a re-review of its own approval based on a 2009 report that concluded the original review of the device suffered from internal FDA departures from processes and procedures.
In March 2010, ReGen sent a letter to the FDA, stating the 2009 report "contains inaccuracies, misrepresentations, speculation, and bias, and omits material information." One year later, the FDA's re-review concluded the implant could not be treated as a surgical mesh but as a novel Class III device and then rescinded the original 510(k) clearance. In opting out of the FDA's Part 16 hearing before final rescinding, ReGen announced it will seek an unbiased review of Menaflex's approval status under U.S. law.
Read the news release about ReGen's Menaflex Collagen Meniscus implant.
Read other coverage about device companies:
- Zimmer Inks $13M Deal With Department of Defense for Orthopedic Implants
- DePuy Parent Johnson & Johnson's CEO Receives 9% Pay Cut
- Former Exactech Rep Pleads Guilty to Paying Illegal Kickbacks to Orthopedic Surgeons
In Dec. 2008, the FDA ruled that the Menaflex Collagen Meniscus implant was as safe and effective as other surgical meshes and cleared it for use by surgeons in the U.S. Two years later, the agency called for a re-review of its own approval based on a 2009 report that concluded the original review of the device suffered from internal FDA departures from processes and procedures.
In March 2010, ReGen sent a letter to the FDA, stating the 2009 report "contains inaccuracies, misrepresentations, speculation, and bias, and omits material information." One year later, the FDA's re-review concluded the implant could not be treated as a surgical mesh but as a novel Class III device and then rescinded the original 510(k) clearance. In opting out of the FDA's Part 16 hearing before final rescinding, ReGen announced it will seek an unbiased review of Menaflex's approval status under U.S. law.
Read the news release about ReGen's Menaflex Collagen Meniscus implant.
Read other coverage about device companies:
- Zimmer Inks $13M Deal With Department of Defense for Orthopedic Implants
- DePuy Parent Johnson & Johnson's CEO Receives 9% Pay Cut
- Former Exactech Rep Pleads Guilty to Paying Illegal Kickbacks to Orthopedic Surgeons