FDA Says Medtronic Addressing Concerns, Sends Letter Anyway

In what some devicemakers are referring to as the “new FDA way,” Medtronic has received a warning letter even though the company has adequately addressed the agency’s concerns. The FDA acknowledges receiving several responses from Medtronic to a Feb. 4 Form 483. “You appear to be addressing our concerns,” the agency says in the warning letter. Medtronic provided responses to all the observations, company spokesman Brian Henry said. No date has been set for a follow-up inspection.
Devices & Diagnostics Letter