Devices

FDA Warning Letter to Dental Device Maker

FDA has sent a Warning Letter to dental device maker DiamoDent (Anaheim, CA) after an inspection last year cited the firm over quality system regulation deviations. The firm makes Class dental prosthetic permanent and temporary implants and abutments. Among the citations in the letter are:

1.    Failure to confirm that design output meets design input requirements during design verification.

2.    Failure to adequately validate software used as part of production and quality systems for its intended use according to an established protocol,

3.    Failure to review, evaluate and investigate, where necessary, complaints involving the possible failure of a device to meet any of its specifications

4.    Failure to establish and maintain procedures for design review

Additionally, FDA said that DiamoDent is marketing its devices for use with dental implant systems that are not listed in the cleared indications. “Your dental prosthetic abutments and implant 510(k)s have FDA cleared Indications for Use which list a limited number of particular manufacturers’ implant systems, with specified sizes, with which your devices are intended to be used,” the letter said. “However, your catalogs and Web site claim ‘compatibility’ and that your devices are ‘fully compatible’ with additional implant systems that are outside the scope of the 510(k)s cleared for your devices. FDA is not aware of any scientific substantiation for these compatibility claims.”

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