Medtronic (NYSE:MDT) announced today that the FDA lifted the warning letter related to its Diabetes business unit headquarters.
In December 2021, the FDA issued a warning letter to Medtronic’s Northridge, California, Diabetes headquarters.
The letter centered around the inadequacy of specific medical device quality system requirements at the Northridge facility. It scrutinized the areas of risk assessment, corrective and preventive action and complaint handling. The letter also related to device recalls and the reporting of adverse events.
At the time, Medtronic said the inspection related to recalls of its MiniMed 600 series insulin infusion pump. It also related to a remote controller device for MiniMed 508 and Paradigm pumps. Medtronic first warned of safety problems with the MiniMed 600 pumps in November 2019. The recall initially involved 322,005 MiniMed 630G and MiniMed 670G pumps in the U.S.
In October 2021, the company expanded the Class I recall. This action replaced all MiniMed 600 series insulin pumps that contain the clear container ring. That brought the total tally of devices recalled in the U.S. to 463,464.
Medtronic’s road to resolving the letter
Shortly after the company received the letter, CEO Geoff Martha said the letter likely would impact regulatory timelines for next-generation diabetes technologies. It may have done so, but just last week, the FDA approved the next-generation MiniMed 780G insulin pump with Guardian 4 sensor technology. Medtronic had said last fall that it achieved 90% of the FDA’s action items pertaining to the letter.
Medtronic said today that the resolution follows ongoing remediation from the company. It took proactive actions to continue to strengthen its quality systems, according to a news release. All regulatory restrictions associated with the letter are resolved, the company said.
“We’re very thankful to the agency for working with us so collaboratively to ensure we’re able to work as quickly as possible to address the needs of the diabetes community,” said Que Dallara, EVP and president of Medtronic Diabetes. “Clearing this latest regulatory milestone allows us to focus on what’s most important – delivering innovations that address unmet needs for the individuals with diabetes we have the privilege to serve.
“It’s an honor that we never take for granted and our commitment is to ensure we’re putting patients first and prioritizing safety and quality above all.”