FDA Advisory Committee Chair, Dr. John Kelly, Weighs in on ReGen controversy |

FDA Advisory Committee Chair, Dr. John Kelly, Weighs in on ReGen controversy

FDA Advisory Committee Chair Weighs in on L’Affaire ReGen (WSJ)

Device Manufacturer Says Politics, Not Science is Driving FDA’s Actions (ReGen Press Release)

FDA Determines Knee Device Should Not Have Been Cleared for Marketing (FDA)

FDA Panel Questions the Benefits of Regen’s Menaflex Meniscus Repair Implant – March 2010

This is a dangerous precedent.   What impact will this have on your 510(k) cleared products?   Below are some stories leading up to the decision…

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