FDA Plans Guidance on Device Enhancement versus Recall
The FDA plans to issue clarifying guidance to address confusion among devicemakers about what exactly constitutes an enhancement and what qualifies as a recall, an FDA official says. “Devicemakers have expressed concern that sometimes when a change to a product is made to make it safer, more effective and easier to use, the agency characterizes those changes as a recall — and they’re not recalls,” said Steven Silverman, director of the FDA’s Center for Devices and Radiological Health’s Office of Compliance. International Medical Device Regulatory Monitor
Come for this valuable opportunity to hear FDA officials discuss regulatory plans and objectives — and ask questions you need answered; learn from device industry experts, consultants and other experts with actionable tips and strategies you can take straight back to the office; and network with other professionals who understand your challenges; share war stories and insights over a drink. Register Today.Read More
The FDA's new enforcement plan makes one thing clear: Developing a successful CAPA program has never been more important. But creating an FDA-proof CAPA isn’t easy. If only you could pick the brain of someone who is coping successfully with CAPA — the best and the brightest, an industry leader who has devised programs, procedures and solutions that have put companies out in front with the FDA. Well, you can. Register today.Read More
The FDA’s cadre of freshly trained inspectors — many of whom come directly from industry — and increased focus on specialized inspections are making it harder than ever to predict the outcome of your next FDA inspection. Unless, of course, you have Surviving an FDA Inspection at your fingertips. If you could spend less than $400 to get your drug manufacturing facility fully prepared to face a tough inspection by the FDA, would you even hesitate? ... Of course not!