Devices

QS, MDR Issues at Curasan AG

A 5/6-5/11/17 FDA inspection at Curasan AG, Frankfurt, Germany, found Quality System and Medical Device Reporting violations in the firm’s manufacturing of Cerasorb Dental, Cerasorb M Dental, Cerasorb Perio, Revios Implant System, IngeniOs HA (Osborne Dental), IngeniOs Beta-TCP Bioactive (Ceracell Dental), and Cerasorb Ortho Foam, according to a just-released 8/23/17 Warning Letter. Specific violations cited were:

failing to establish and maintain procedures for validating device design;
failing to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications; and
failing to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit.

The inspection also found that the company failed to develop, maintain, and implement written medical device reporting procedures.

The firm’s responses to the inspection observations were determined to be inadequate.

Curasan was told to respond with a list of specific steps taken to correct the violations and prevent their recurrence, with documentation of each step 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