Devices

Non-Clinical Bench Performance Guidance Out

FDA has published a guidance, Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions, to describe relevant information that should be included in test report summaries, test protocols, and complete test PMA applications, HDE applications, 510(k) submissions, IDE applications, and De Novo requests. For purposes of the document, non-clinical bench performance testing is defined as performance testing, performed by either a device manufacturer or a third party testing facility, which encompasses all bench testing and will be dependent upon the specifics of the actual device or device type.

Non-clinical bench performance testing includes, but is not limited to, mechanical and biological engineering performance (such as fatigue, wear, tensile strength, compression, and burst pressure), bench tests using ex vivo, in vitro, and in situ animal or human tissue, and animal carcass or human cadaveric testing, FDA says. It excludes biocompatibility evaluation, reprocessing or sterilization validation, human factors, software verification and validation, and computational modeling, because relevant information on these assessments is detailed in associated guidances. Test reports for clinical studies, animal studies, and studies evaluating the performance characteristics of in vitro diagnostic devices are also excluded from the document’s scope.

The agency says the information in the guidance is intended to help ensure that clear and consistent information is provided in premarket submissions containing non-clinical bench performance testing.

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