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Waxman queries FDA on Medtronic recall

This article was originally published in The Gray Sheet

Executive Summary

House Committee on Oversight and Government Reform Chair Henry Waxman, D-Calif., requests information on FDA's oversight of Medtronic's Sprint Fidelis defibrillator leads in an Oct. 22 letter to the agency. Medtronic recalled the leads Oct. 15 due to a propensity for fractures that has been linked to patient deaths (1"The Gray Sheet" Oct. 22, 2007, p. 3). Noting what is "apparently a serious shortcoming in the agency's approval process for these devices," Waxman asks FDA why Medtronic was not required to submit clinical data to support the leads' safety and efficacy, what information Medtronic had provided about the fracture problem and how FDA responded, and whether the agency had created new policies for the oversight of defibrillators. Sen. Chuck Grassley, R-Iowa, sent FDA a similar letter Oct. 16

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