Devices

SynCardia MDR Violations

An 8/14-8/18/17 FDA inspection at SynCardia Systems, Tucson, AZ, found Medical Device Reporting violations associated with the firm’s manufacturing of the SynCardia Total Artificial Heart System, according to a 4/3 Warning Letter. Specific violations cited in the letter were:

failing to report to FDA no later than 30 calendar days after the day that the firm received or otherwise became aware of information, from any source, reasonably suggesting that a device that it markets may have caused or contributed to a death or serious injury; and
failing to adequately develop, maintain, and implement written Medical Device Reporting procedures.

The firm’s responses to the inspection observations were acknowledged and FDA said it was unable to determine the adequacy of the proposed corrective actions.

SynCardia was told to respond with a list of specific steps taken to correct the violations and prevent their recurrence, with documentation of the corrections or corrective actions the firm has taken, and a timetable for completion.

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