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Make sure to submit electronic or written comments on a guidance by the closing date is the first tip given by CDRH in a list, released Aug. 16, of tips, recommendations and instructions on how to submit comments on a guidance. Read More
The FDA has classified the most recent recall of certain Philips Trilogy ventilators as class I, the most serious type of recall as use of the device may lead to serious injury or death. Read More
Incorporating off-the-shelf (OTS) software into medical devices is becoming more common but a new guidance from the FDA advises that when using prepared software from another manufacturer, devicemakers still bear responsibility for continued safe and effective performance of the device. Read More
Illumina received notice in July that the Securities and Exchange Commission (SEC) was conducting an investigation into the company’s acquisition of Grail, requesting documents from the company over the beleaguered acquisition. Read More
In July, the court said that PTAB used incorrect legal framing and conducted an erroneous obviousness analysis in its opinion on separate but related Medtronic patents. Read More
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
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
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