Devices

QS Issues at Circulatory Technology

An 8/22-9/26/18 FDA inspection at Circulatory Technology, Oyster Bay, NY, found Quality System Regulation violations in the firm’s work as a specification developer of the Better Bladder and Bigger Better Bladder medical devices. A just-released 1/28 Warning Letter says the violations were:

failing to perform and document revalidation activities when changes or process deviations occur in the manufacturing operations;
failing to establish and maintain procedures to control the design of the device to ensure that specified design requirements are met;
failing to evaluate complaints to determine whether the complaint represents an even that is required to be reported to FDA under the Medical Device Reporting regulation; and
failing to document all required corrective and preventive actions.

FDA says the company either did not respond to a specific inspection observation or its responses were inadequate. Circulatory Technology was told to take prompt action to correct the violations. It was told to submit a list of steps taken to correct the violations and prevent their recurrence, with documentation for each correction and a timetable for completion. The agency also asked that the company submit on a defined schedule certification by an outside expert consultant that he or she has audited the company’s manufacturing and quality assurance systems relative to Quality System Regulation requirements.

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