Devices

‘Objectionable Conditions’ Found at Dentist’s Clinical Site

A 9/18-10/16/14 FDA inspection found objectionable conditions at a clinical site operated by Dr. William Domb in Upland, CA, who was sponsor/investigator of the significant risk clinical study entitled “Expectations for IRB Research Associations and Oxygen/Ozone Simplified and Suggested Research Treatment Protocols: A Historical Review of Current Trends of Dental Colleagues.” A just-released 3/24/15 Warning Letter says the inspection was conducted under a program designed to ensure that data and information contained in requests for IDEs, PMAs, and 510(k)s are scientifically valid and accurate. An additional program objective is to ensure that human subjects are protected from undue hazard or risk during scientific investigations. Specific violations noted in the letter were:

failing to submit an IDE application to FDA and obtain approval of the IDE from the agency and an institutional review board before allowing subjects to participate in the investigation of a significant risk device;
failing to prepare an adequate investigational plan;
failing to select investigators qualified by education and experience and failing to obtain signed agreements from participating investigators;
failing to ensure that informed consent was obtained; and
failing to ensure proper monitoring of the investigation.

FDA says Domb’s responses to the inspection observations were inadequate. He was told to provide documentation of additional actions he has taken or will take to correct the violations and to prevent their recurrence, with projected completion dates and a plan for monitoring the corrective actions’ effectiveness.

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