Devices

Multiple Violations in NeuroField Inspection

A 9/28-10/6/21 FDA inspection at the NeuroField medical device operation in Bishop, CA, found multiple violations in the firm’s manufacturing of neurostimulation and electroencephalogram signal processing devices and software products. A 2/28 Warning Letter says the firm’s devices are adulterated because the company does not have an approved PMA or IDE in effect for the products. The devices also are misbranded, FDA says, because NeuroField did not notify the agency of its intent to introduce the devices into commercial distribution.

The letter says two of the firm’s devices have been registered and listed with FDA as biofeedback devices but information collected during the inspection and from other sources shows the devices are intended for uses that exceed or otherwise differ from the classification for biofeedback devices.

The inspection also found Quality System Regulation violations, FDA says. Specific violations were:

failing to adequately maintain complaint files and establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
failing to adequately establish procedures for corrective and preventive action;
failing to adequately establish procedures to ensure that all purchased or otherwise received products and services conform to specified requirements;
failing to establish procedures to ensure equipment is routinely calibrated, inspected, checked, and maintained;
failing to adequately establish procedures for management review; and
failing to adequately establish procedures for quality audits.

FDA says the firm’s responses to the inspection observations were either inadequate or their adequacy could not be determined.

NeuroField 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 the corrections and corrective actions, and a schedule for completing the work.

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

Read more

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