Devices

Neurotris Illegally Marketing Devices: FDA

A 4/4-4/25 FDA inspection at Neurotris, Inc., doing business as A1 Engineering in Irvine, CA, determined the firm manufactures and distributes several unapproved Class 2 powered muscle stimulator devices, sometimes known as the Neurotris Body System. A 10/27 Warning Letter says the firm is illegally marketing the devices because it does not have an approved PMA or IDE in effect for them and because it did not notify the agency of its intent to introduce the devices into commercial distribution.

The letter says the devices have intended uses that exceed the indication for the 510(k) clearance for the company’s original two devices. Later devices have different technical characteristics from the original two, FDA says, which would require a new 510(k).

FDA says there is a significant risk to the new anatomical areas of use that are promoted for some of the devices. The agency also raises issues about electrodes, gels, and sprays the firm uses or promotes.

In addition, the following Quality System Regulation violations are cited:

failing to adequately establish and maintain procedures for design validation;
failing to adequately establish and maintain procedures for corrective and preventive action;
failing to adequately establish and maintain procedures for rework; and
failing to evaluate and select potential suppliers on their ability to meet specified requirements and define the type and extent of control to be exercised over suppliers.

The firm’s responses to the inspection observations were not adequate, the letter says. Neurotris was told to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with documentation of the corrections, and a schedule for completing them.

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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