Devices

2 Draft Dental Device Guidances Out

FDA has published draft guidances on dental composite resins and curing lights. The first, Dental Composite Resin Devices—Premarket Notification (510(k)) Submissions, has draft recommendations for dental composite resin 510(k)s. The document says the device is intended to fill and restore defects or carious lesions in teeth. It may be supplied as a two-part base and catalyst system that is self-cured or a one-part system that is cured through photoinitiation, the agency says.

FDA says its recommendations reflect current review practices and are intended to promote consistency and facilitate efficient reviews of submissions.

When finalized, the draft will supersede a 10/26/2005 guidance.

The second draft, Dental Curing Lights—Premarket Notification (510(k)) Submissions, says the devices in the guidance’s scope include non-ionizing optical radiation intended to photopolymerize dental restorative resins. FDA says it is issuing the document to clarify and provide recommendations for premarket submissions for dental curing lights and to reference relevant consensus standards to promote consistency and facilitate efficient review of the submissions.

When finalized, the draft will supersede a 3/27/2006 guidance.

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