Devices

7 QS Violations in Dexcom Inspection

A 10/21-11/7/2024 FDA inspection at Dexcom in San Diego, CA, and a 6/10-6/14/2024 inspection at the firm’s facility in Mesa, AZ, found seven Quality System Regulation violations in its manufacturing of G6 and G7 continuous glucose monitors. A just-released 3/4 Warning Letter says the specific violations were:

failure to establish procedures for monitoring and control of process parameters for a validated process;
failure to establish procedures to adequately validate a process whose results cannot be fully verified by subsequent inspection and test;
failure to adequately establish procedures for design input;
failure to establish procedures for design changes;
failure to adequately establish procedures for design output;
failure to establish adequate procedures for design validation to ensure that devices conform to defined user needs and intended uses; and
failure to establish adequate procedures for corrective and preventive actions.

The letter says the firm’s responses to the inspection observations either were inadequate or their adequacy could not be determined. FDA says it determined that Dexcom does not have approved PMA or IDE applications in effect for its devices and also that it introduced the devices into interstate commerce with major changes or modifications.

Dexcom was told to act promptly to correct the violations and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with documentation for the actions 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

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