Devices

QS Violations in NeuroSync Inspection

A 1/6-2/5 FDA inspection at the NeuroSync facility in Holliston, MA, found Quality System Regulation violations in the firm’s manufacturing of the Eye-Sync eye assessment virtual reality headset and tablet computer. A 5/9 Warning Letter says the specific violations were:

failure to establish and maintain procedures to control the design of the device to ensure that specified design requirements are met;
failure to establish and maintain procedures for implementing corrective and preventive action, including implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems;
failure to establish and maintain procedures to ensure that all purchased or otherwise received products and services conform to specified requirements; and
failure to establish and maintain procedures for acceptance activities, including inspections, tests, or other verification activities.

The letter says the firm’s responses to the inspection observations were inadequate. It also says the inspection found a Medical Device Reporting violation and a lack of a unique device identifier on its product.

NeuroSync was told to take prompt action to address all the violations in the letter. It was to respond with a list of specific actions it took to correct the violations and prevent their recurrence, with documentation of each action and a schedule 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

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

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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