We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA proposed rule changes May 6 critical to determining which agency product center takes the lead on regulatory oversight of a particular combination product.
Boston Scientific revealed late last week that it intends to make slight alterations to its high-profile Taxus drug-eluting stent system to address reports that surgeons have had difficulty withdrawing balloons used to place the devices in patients.
While it’s still too early to tell what regulatory course Daniel Shultz will take in his tenure as acting chief of the FDA’s Center for Devices and Radiological Health (CDRH), he told D&DL last week that he doesn’t plan to stray far from the path that his predecessor, David Feigal, blazed.
The future of the FDA’s Center for Devices and Radiological Health (CDRH) will be focused on meeting the goals established by the Medical Device User Fee and Modernization Act (MDUFAMA), said the center’s new acting director Dan Schultz
The number of complaints and disputes against the Center for Devices and Radiological Health (CDRH) more than doubled in 2003, according to agency ombudsman Les Weinstein’s annual report released March 31.
Integrating mortality data into trial endpoints and throughout the total product life cycle is key for clinical trial sponsors, says Bram Zuckerman, director of the cardiovascular devices division at the FDA’s Center for Devices and Radiological Health.
Devicemakers should consider risk management over the total product life cycle using a top-down approach, FDA staffers and industry experts said last week at the Association for the Advancement of Medical Instrumentation/FDA international conference on medical device standards and regulations.