The entire orthopedic industry is watching this unprecedented FDA relook?
Does the FDA have the authority to take back a 510(k)? If so, on what basis? What impact will this have on your 510(k) cleared products? Read recent publications below…
- FDA Agenda and Meeting Materials FDA.gov
- FDA Wrestles With Undoing Decision WSJ (Mar 22)
- UPDATE: FDA:Not Enough Data From ReGen To Show Knee Device Safe WSJ (Mar 19)
- ReGen: Resurrection or Final Nail OrthopedicsThisWeek (Mar 4)
- FDA: Menaflex Clearance Shows “Definite Threats” to the 510(k) Process HealthPointCapital (Sept 24)
- FDA Reports Political Pressure Over Implant Washington Post (Sept 25)