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Extended timelines alone are not sufficient to achieve transition to the new European medical device regulations, Team NB — the European Association of Medical devices Notified Bodies — says in a position paper it issued Thursday, explaining that manufacturers are still lagging in applying for certification. Read More
New resources are needed to support CMS’s Coverage and Analysis Group’s coverage decisions for FDA-approved breakthrough medical devices, says a new report from AdvaMed and Health Management Associates, to decrease the review time for medical devices. Read More
The complex process of regulating combination products begins with the FDA’s determination of which center — CDRH, CBER or CDER — will take the lead role in overseeing a product’s development, but even after that determination is made, the way regulations are applied opens up another layer of complexity. Read More
Datascope/Maquet/Getinge’s Cardiosave Hybrid and Rescue Intra-aortic Balloon Pump (IABP) is seeing a recall deemed class I — the most serious type of recall as use of the device may cause serious injury or death — for the third time in the past nine months, this time for a potential electrical shutdown. Read More
Over the past week, the FDA issued final guidance on acceptable intake limits for nitrosamines and draft guidances on QTc information in human prescription drug and biological product labeling, classification categories for biosimilars, formal meetings for biosimilars and postmarketing approaches in clinical trials. Read More
The FDA’s Quality System Regulation mandates that devicemakers have procedures for documenting, verifying and validating all design changes before they are implemented. Read More
A federal appeals court handed another win to Axonics in its ongoing battle with Medtronic over claims that Medtronic’s patents for a sacral-nerve stimulation device are invalid. Read More
Cybersecurity patches — both proactive to address potential threats and reactive to respond to threats that have already occurred — can be expected to be part of any connected device’s lifecycle. But in the medical device world, these patches constitute design changes, which are strictly regulated, says Eric Henry, a senior quality systems and compliance adviser in the law firm King & Spalding. Read More
Upcoming events in the coming weeks include six FDA advisory committee meetings as well as the GMP Quality Management vSummit and webinars from FDAnews, a WCG company on reliability assessment and medical device risk management tools. Read More
The center has received more submissions for novel devices over the past twelve months than during any 12-month period since the FDA began tracking in 2015. Read More