Drugs

Medtronic’s MiniMed 780G Gets FDA Approval

David McFarland

— 1 min read
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After a delay caused by an FDA 2021 inspection and Warning Letter, the agency has approved Medtronic’s MiniMed 780G System that includes modifications to the device’s SmartGuard (SG) Technology and expanding the indications for use to include the Guardian 4 Sensor. The device is intended for “continuous delivery of basal insulin (background insulin) at selectable rates, and the administration of insulin boluses (a single large dose of medicine) at a selectable amount for the management of Type 1 diabetes mellitus in persons seven years of age and older requiring insulin,” an agency release says.

The system is also intended to continuously monitor glucose values in the fluid under the skin, FDA says. The SG technology allows the device to be programmed to automatically adjust insulin delivery based on continuous monitoring sensor values and can pause insulin delivery when the value falls or is predicted to fall below predefined threshold values, it adds.

A 6/7/21-7/7/21 FDA inspection at Medtronic’s facility in Northridge, CA, found Quality System Regulation and Medical Device Reporting violations in the firm’s work manufacturing the MiniMed 600 series insulin infusion pumps and software and remote controllers used with the Paradigm and MiniMed series insulin infusion pumps. A 12/9/21 Warning Letter outlined specific violations, which included:

  • failing to adequately establish procedures for corrective and preventive action;
  • failing to review, evaluate, and investigate complaints involving the possible failure of a device to meet any of its specifications;
  • failing to submit a report to FDA no later than 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury; and
  • failing to submit a report to FDA no later than 30 calendar days after the day the firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that the firm markets has malfunctioned and this device or a similar device that it markets would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

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