Devices

FDA Guide on MDR Reporting

FDA has released a final guidance on “Medical Device Reporting (MDR) for Manufacturers” that is intended to help companies meet applicable reporting and recordkeeping requirements for certain device-related adverse events and malfunctions. The document covers MDR requirements to develop, maintain, and implement written procedures for identifying and evaluating all medical device events (e.g., malfunctions, serious injuries and deaths) to determine whether the event is an MDR reportable event. It also covers requirements to establish and maintain complete files for all complaints concerning medical device events.

Additionally, the guidance focuses on common errors in MDR reports. For example, it says a common error is duplicate report sequence numbers provided in the Manufacturer Report Number box and Block G-9. “Each report must have its own sequence number to avoid confusion,” it says. “You should not use the same sequence number on more than one report in any given year.” Another common error is having multiple devices or events included in the same report. “If more than one of your devices is involved in a single MDR reportable event, and it is not apparent which device may have caused or contributed to the event, then you must submit a separate report for each of your devices involved in the event,” the agency says.

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