Devices

Multiple Violations at WAVi Co.

A 3/23-3/29 FDA inspection at WAVi Co. in Denver, CO, found that the firm manufactures and distributes the “WAVi Desktop,” intended to collect, analyze, and clinically interpret data to aid in the assessment or diagnosis of patients with a variety of potential neurological conditions. A 10/20 Warning Letter says the device is adulterated because the firm does not have an approved PMA or an approved application for an IDE in effect. The device also is misbranded, the letter says, because the firm introduced or delivered it for introduction into interstate commerce without submitting a required premarket notification to FDA.

The letter says company officials said during the inspection that the WAVi Desktop is for research use only. However, the company did not provide evidence of having an approved IDE for the device and did not provide any evidence to support a claim that it is IDE-exempt.

FDA says its review of the firm’s customer list indicates it is marketing to commercial firms as well as academic institutions and information on the company’s Web site supports the notion that the device is being marketed for more than research purposes.

The inspection also identified these Quality System Regulation violations:

failing to perform validation of device software;
failing to validate a process whose results cannot be fully verified by subsequent inspection and test;
failing to adequately maintain device history records that include or refer to the acceptance records that demonstrate the device is manufactured following the device master record;
failing to maintain device master records; and
failing to establish procedures for, and conduct, quality audits.

WAVi was told to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with documentation of the corrections or corrective actions, and a timetable for completing the corrections.

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