Devices

How to Boost Quality System Inspection Success: Consultant

KEB consultant Adam Atherton says his analysis of FDA quality system inspection data over time yielded three takeaways to ensure future success. In a Med Device Online guest column, Atherton says agency inspections of medical device quality systems are driven by either the older, but still relevant, quality system inspection technique or the more recently developed medical device single audit program (MDSAP) model. “It is unknown if these different audit approaches result in different outcomes, but it is unlikely,” he says. “I expect the MDSAP methodology identifies quality system gaps quicker due to the more rigorous and systematic approach, though.”

His three steps that can be taken now to help ensure success in future audits, submissions, and development are:

document and follow processes;
check to ensure there is clarity at the interfaces; and
challenge internal auditors to integrate the two FDA methodologies into their approach so the organization is better prepared for an actual audit.

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