Devices

Dental Bone Graft Animal Study Guide

FDA has published a draft guidance, Animal Studies for Dental Bone Grafting Material Devices—Premarket Notification (510(k)) Submissions, with recommendations for animal studies that may assist manufacturers in complying with some special controls for dental bone grafting material devices. The document says the device is a material that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

When finalized, the guidance is to:

provide recommendations for animal studies that may assist manufacturers in complying with some special controls for dental bone grafting material devices;
provide recommendations for manufacturers who choose to combine an animal study with the biocompatibility evaluation of implantation;
augment the recommendations in the Class II Special Controls guidance Dental Bone Grafting Material Devices; and
promote consistency and facilitate efficient review of submissions for dental bone grafting material devices.

FDA will receive comments on the draft by 5/28.

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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