Devices

Two Guidances on Dental Composites and Curing Lights

FDA has released two guidance documents on dental-related medical devices.

The one guidance, Dental Curing Lights – Premarket Notification (510(k)) Submissions, provides recommendations for 510(k) submissions for dental curing lights that emit non-ionizing optical radiation intended to photopolymerize dental restorative resins. FDA is issuing this guidance to clarify and provide recommendations for premarket submissions for such devices. It includes references to relevant consensus standards.

The other guidance, Dental Composite Resin Devices – Premarket Notification (510(k)) Submissions, provides recommendations for 510(k) submissions for dental composite resins used in dentistry, which are intended to fill and restore defects or carious lesions in teeth. It says such devices can be supplied as a two-part base and catalyst system that is self-cured or a one-part system that is cured via photoinitiation. The document does not cover resin restoratives intended for other uses, such as cementing, coating, fixation, and temporary restoration, the agency says.

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