Devices

3 IMDRF Clinical Documents Published

The International Medical Device Regulators Forum (IMDRF) has published three clinical final documents. The first, “Clinical Evidence—Key Definitions and Concepts,” is intended to (1) introduce the concepts of clinical evaluation and clinical evidence; (2) examine the relationship between clinical investigation, clinical data, clinical evaluation, and clinical evidence; and (3) serve as guidance to all those involved in the generation, compilation, and review of clinical evidence sufficient to support the marketing of medical devices.

The second document, “Clinical Investigation,” provides guidance in relation to when a clinical investigation should be undertaken for a medical device to demonstrate compliance with the relevant essential principles and the general principles of clinical investigation involving medical devices. “Given the wide diversity of medical devices and their associated risks,” the document says, “this document is not intended to provide comprehensive guidance for clinical investigations of specific medical devices.”

The final document, “Clinical Evaluation,” answers a series of questions about the definition of clinical evaluation, why such evaluation is important, what the clinical evaluation process is, and how detailed a clinical evaluation should be.

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