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…
- FDA Agenda and Meeting Materials FDA.gov (Jul 27, 2010)
- FDA Wrestles With Undoing Decision WSJ (Mar 22, 2010)
- UPDATE: FDA:Not Enough Data From ReGen To Show Knee Device Safe WSJ (Mar 19, 2010)
- ReGen: Resurrection or Final Nail OrthopedicsThisWeek (Mar 4, 2010)
- FDA: Menaflex Clearance Shows “Definite Threats” to the 510(k) Process HealthPointCapital (Sept 24, 2009)
- FDA Reports Political Pressure Over Implant Washington Post (Sept 25, 2009)