Devices

Multiple QS Violations at ARB Medical

An 8/5-8/11/15 FDA inspection at ARB Medical, Minneapolis, MN, found multiple Quality System Regulation violations in the firm’s manufacturing of polymeric surgical meshes. A 12/22/15 Warning Letter from the agency’s Minneapolis District Office says that violations included:
failing to adequately validate, according to established procedures, a process whose results cannot be fully verified by subsequent inspection and test; failing to review and approve design output before release; failing to use design validation to ensure that the device conforms to defined user needs and intended uses; failing to adequately establish procedures for acceptance of incoming product; failing to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit; failing to adequately establish procedures for corrective and preventive actions; failing to report to FDA no later than 30 calendar days after the day that the firm receives or otherwise becomes aware of information from any source that reasonably suggests that a device it markets has malfunctioned and that this device or a similar device that it markets would be likely to cause or contribute to a death or serious injury; and failing to adequately develop, maintain, and implement written Medical Device Reporting procedures.

ARB was told to take prompt action to correct the violations and to respond with an update on the steps it has taken, 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

Read more

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