Devices

Many Device Makers ‘Not Ensuring Label Compliance’

Prisym ID says that too many medical device companies are not aware of or fail to follow FDA regulations on labeling of their products. “The continual tightening of regulation around the packaging and labeling of medical devices has so far failed to stimulate a transformation of labeling infrastructure and approach among global device manufacturers,” the company says in an online post. “Understandable concerns about the cost and consistency of new technologies has convinced many companies to maintain traditional methods of labeling inspection, but their persistence with an old approach risks the potential breach of global regulations and continues to yield the same results.”

The post reports that more than half of all FDA recalls of medical devices since the first quarter of 2014 were caused by packaging and/or labeling error. And it says that a large percentage of the industry appears to be oblivious of FDA regulations on quality requirements for label inspection. “With the stakes so high,” it says, “finding a workable and cost-effective solution to the problem is becoming a major priority.”

Agency regulations say that all medical device and pharmaceutical labels must be suitably checked for errors and accuracy. Prisym says that the scope of the inspection extends beyond assuring the pre-production validity of the data printed on the label, or multipage document such as the instructions for use, to the quality and legibility of the final print output. “The business challenge for medical device organizations,” the post says, “is to ensure that robust systems are in place to maintain compliance, mitigate risk, and protect patient safety throughout the end-to-end labeling process, while at the same time maintaining cost-effective, efficient, and profitable operations.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome