Devices

QS, MDR Violations at Datascope

A 3/19-6/11 FDA inspection at Datascope Corp., Fairfield, NJ, found Quality System regulation and Medical Device Reporting regulation violations in the firm’s manufacturing of the Sensation Plus 8Fr intra-aortic balloon catheter, Mega 7.5 Fr intra-aortic balloon catheter, Sensation Plus 7.5 Fr intra-aortic balloon catheter, and cardiopulmonary bypass tubing packs. A 9/11 Warning Letter says specific violations were:

failing to establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants;
failing to establish and maintain procedures for the identification, documentation, validation or, where appropriate, verification, review, and approval of design changes before their implementation;
failing to submit a report to FDA no later than 30 days after the day that the firm received or otherwise became aware of information from any source reasonably suggesting that a device it markets may have caused or contributed to a death or serious injury;
failing to submit a report to FDA no later than 30 days after receiving or otherwise becoming aware of information that a device the firm markets has malfunctioned and that device or a similar device that the firm 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.

Datascope was told to take prompt action to correct the violations and 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