FDA Commissioner Scott Gottlieb recently emphasized that “the most impactful way that we can promote innovation and improved safety in the 510(k) program is to drive innovators toward reliance on more modern predicate devices or objective performance criteria when they seek to bring new devices to patients.” Common sense indicates that when conducting comparative testing […]
Zimmer hip implant manufacturing subject to FDA action
Zimmer Holdings Inc. has a documented history of releasing flawed hip replacement implants onto the U.S. market. Two of its products, the Zimmer M/L Taper Prosthesis and the Zimmer Durom Acetabular Component, have been linked to health problems and the need for additional surgeries in some patients. According to the FDA notice, the Zimmer devices […]