Devices

ISO 10993-1 Clarifying Guidance

FDA has published a guidance, Use of International Standard ISO 10993-1, “Biological Evaluation of Medical Devices—Part I: Evaluation and Testing Within a Risk Management Process, to provide further clarification and updated information on using the designated ISO standard to support applications to FDA. The agency says the document is to assist the medical device industry in preparing PMAs, HDEs, IDEs, 510(k)s, and de novo requests for medical devices that come into direct or indirect contact with the human body. The guidance also incorporates several considerations, including the use of risk-based approaches to determine if biocompatibility testing is needed, chemical assessment recommendations, and recommendations for biocompatibility test article preparation for devices with submicron or nanotechnology components and devices made from in situ polymerizing and/or absorbable materials, FDA says.

The guidance contains an Introduction, Scope, Risk Management for Biocompatibility Evaluations, ISO 10993—Part I and the FDA-Modified Matrix, General Biocompatibility Testing Conditions, Test-Specific Considerations, Chemical Assessment, Labeling Devices as “-Free,” and six attachments.

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