Devices

Changes Sought in Device Animal Study Guidance

Cook Group says that while an FDA draft guidance on general considerations for animal studies for medical devices is generally well written and reasonable in terms of the types of controls and level of detail that need to be specified in studies to develop valid scientific data, there are cases in which it is unnecessarily restrictive or overly burdensome. There also are cases, it says, when it is not clear what the document is proposing.

AdvaMed’s comment letter says it is important to note that the guidance’s stated scope is not consistent with statements in its introduction and various other parts and confuses a reader. The association says that in its Scope section, the guidance says it applies to in vivo laboratory studies, which are defined as safety studies submitted in support of a regulatory submission. However, it says, other parts of the document refer to supporting the safety and performance of a medical device, including performance and handling, and evaluating a device’s efficacy or demonstrating proof of principle. “A clear definition of the scope of the guidance will avoid confusion and misunderstanding,” AdvaMed says. “It might be helpful to expand on what FDA considers to be ‘safety,’ how it is defined, how it can be determined, and what influences it.” AdvaMed also requests clarifications and revisions through many line-by-line comments.

Johnson & Johnson associates itself with AdvaMed’s comments and identifies several key issues for additional focus.

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

Read more

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