Devices

QS Violations at Invacare Facilities

FDA 5/25-6/24 inspections at three Invacare manufacturing facilities identified Quality System Regulation violations in the firm’s manufacturing of a variety of Class 2 oxygen concentrators intended for patients with respiratory disorders requiring supplemental oxygen. An 11/18 Warning Letter says specific violations were:

failing to investigate any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications, unless such investigation has already been performed for a similar complaint and another investigation is not necessary;
failing to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
failing to establish and maintain adequate procedures for implementing corrective and preventive action, including requirements for using appropriate statistical methodology where necessary to detect recurring quality problems;
failing to establish and maintain procedures for implementing corrective and preventive actions; and
failing to submit a 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, that reasonably suggests that a device that the firm markets has malfunctioned and this device or a similar device that it markets would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

Invacare was told to take prompt action to correct the violations and prevent their recurrence and to respond with a list of specific steps it has taken, with documentation of each step, and a timetable for completing the steps.

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