Devices

New Report Shows Industry Struggling to Meet UDI Compliance

A new report indicates that many medical device makers are not ready to implement Unique Device Identification (UDI) labeling based on FDA compliance deadlines. For example, next month the labels and packages of Class 2 devices must bear a UDI, according to the agency. However, the report from Loftware and USDM Life Sciences shows that only 15% of respondents are currently compliant with the next phase of regulation. The report is based on a survey of , 120 medical device industry professionals.

The report also says that 93% of the companies that responded said UDI requirements have had a major or at least noticeable impact on their existing labeling processes. “Also, only half felt that their current barcode labeling software solution would be able to scale to meet long-term UDI regulations and other evolving international requirements, as well as allow them to expand into new markets,” the report says. “This in part is due to the fact that many companies are not standardized on a single solution, with over 70% reporting that they currently maintain between two and four barcode labeling software solutions.”

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