Devices

Multiple Issues at Germany’s DRG Instruments

An 11/4-11/7/2024 FDA inspection at DRG Instruments GmbH in Marburg, Germany, found multiple violations in the firm’s manufacturing of several in vitro diagnostic devices. A just-released 3/31 Warning Letter says two of the firm’s diagnostic devices are adulterated because DRG does not have an approved application for PMA or IDE in effect. Those devices also are misbranded, the letter says, because DRG did not notify FDA of its intent to introduce them into commercial distribution, with major changes or modifications to the intended use, without submitting a new premarket application to FDA.

Quality System Regulation violations listed in the letter were:

failure to adequately establish and maintain procedures for implementing preventive and corrective action; and
failure to adequately maintain records of complaint investigations that include required information.

The inspection also found that DRG failed to develop, maintain, and implement written Medical Device Reporting procedures, FDA says.

The agency said it was refusing entry of the two unapproved diagnostic devices into the U.S. It also noted that the firm’s Web site contains a tab labeled FDA Approved Tests that lists several tests for which approval had not been granted.

DRG 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.

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’

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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

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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