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Home » Medtronic warning letter highlights critical nature of risk evaluation in devices
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Medtronic warning letter highlights critical nature of risk evaluation in devices

Dec. 29, 2021
By Mark McCarty
Some U.S. FDA warning letters are mostly about documentation, but the key consideration in the widely publicized Dec. 9 FDA warning letter to Dublin-based Medtronic plc seems to be whether Medtronic had a proper understanding of the risk created by malfunctioning infusion pump retainer rings. That difference of opinion regarding risk took a significant bite out of the company’s shares and boosted the fortunes of its rivals in the diabetes space, a cautionary tale regarding the hazards associated with a failure to understand how the FDA sees the risk of device malfunction. The FDA had reported in October 2021 a pair of recalls of Medtronic’s Minimed insulin pumps, although one of the issues cited was related to cybersecurity concerns. The two recalls affected nearly half a million units combined, and could have significantly affect access for some patients.
BioWorld MedTech Regulatory Diabetes U.S. FDA

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