Devices

CDRH on Device Tools Qualification Benefits

A CDRH webinar on the Medical Device Development Tools (MDDT) voluntary qualification program listed its benefits as (1) leveraging advances in regulatory science that help to bridge the gap between research and development of medical devices and the delivery of high quality, safe, and effective devices to patients; and (2) a qualified MDDT can be used by multiple sponsors across multiple medical device development programs. CDRH medical device development tools program director Hilda-Scharen Guivel told participants that the program’s intent is to promote development and use of tools to streamline device development and regulatory evaluation.

Questions to consider when determining whether to qualify a proposed MDDT, she said, include whether:

the MDDT is adequately described;
the proposed context of use is adequately and appropriately defined;
the available scientific evidence demonstrates that the MDDT reliably and accurately measures what is intended, is scientifically plausible, and is reasonably likely to predict the outcome of interest; and
the advantages outweigh disadvantages of making decisions based on measurement obtained using the MDDT within the specified context of use and available strength of evidence.

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