Devices

Stakeholders Appreciate IVD Draft Guidance

Three industry stakeholders say they appreciate an FDA draft guidance on investigational IVDs (in vitro diagnostics) and suggest changes they would like in the draft. The Biotechnology Innovation Organization (BIO) says in a 3/19 comment letter that it appreciates that the guidance provides several examples of IVD uses that are considered to be investigational, such as identifying subjects for study enrollment criteria, predicting increased or decreased risk for serious adverse events from the therapeutic product, determining appropriate dosing levels/amounts, and others. However, it continues, its members would benefit from additional clarification in what would constitute a non-investigational device study that would fall outside the scope of IDE requirements. The letter lists additional areas for which BIO would like further clarification.

AdvaMedDx says it applauds inclusion in the draft of examples of how IVDs, both assays and software, are used in therapeutic product clinical trials. “We would appreciate an extended, comprehensive list of the known types of uses of IVDs in therapeutic product trials and clear instruction as to whether certain uses are considered investigational,” it says. The comment also asks that the agency cross-reference other relevant guidances in the final guidance.

In its response, Merck offers one comment on invasive blood sampling, asking FDA to reconsider including biopsy procedures for the purposes of significant risk determination for oncology trials and similar therapeutic areas

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