The International Medical Device Regulators Forum late last month unveiled its long-awaited plan for device identification, pushing for a “highly interoperable” and harmonized system to globally track medical devices.
The International Medical Device Regulators Forum (IMDRF) has issued two draft standards on harmonized audit criteria and training requirements for both regulatory agencies and third-party auditing organizations.
Abbott is recalling U.S. supplies of its FreeStyle InsuLinx blood glucose meters, due to a problem with readings at very high glucose levels — the second such recall by a diabetes product maker in a month.
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!