Devices

Medical Device Study Site Violations

A 9/6-9/27/Entellus Medical, Plymouth, MN, found “objectionable activities” in the firm’s role as sponsor of a significant risk study of the XprESS Multi-Sinus Dilation System and the Path Assist Confirmation Tools conducted under an IDE, according to a just-released 4/6 Warning Letter. Specific violations noted on an FDA-483 were:

failing to secure compliance with investigators who are not complying with the signed agreement or investigational plan and the institutional review board (IRB) approved protocol;
failing to obtain approval of a supplemental application and IRB approval prior to implementing a change to the investigational plan;
failing to promptly inform the reviewing IRB and FDA of significant new information about the investigation; and
failing to have both IRB and FDA approval of an application n or supplemental application before beginning an investigation or part of an investigation.

Entellus was told to respond with a correction plan with completion dates for each action to be accomplished as well as a plan for monitoring the effectiveness of the corrective actions.

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