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CPI fails to gain "manufacturer" tracking status for devices it distributes for others.

This article was originally published in The Gray Sheet

Executive Summary

CPI NEEDS WRITTEN PERMISSION FROM MANUFACTURERS TO CONDUCT TRACKING for products it distributes but does not manufacture, Lillian Gill, director of the Office of Compliance at FDA's Center for Devices and Radiological Health, says in letter to the firm dated Sept. 15. Denying a petition from Guidant division Cardiac Pacemakers, Inc. that asked that the firm be authorized to perform device tracking responsibilities on behalf of manufacturers of products it distributes ("The Gray Sheet" May 23, 1994, p. 19), Gill says the agency will reconsider the request if CPI "enters into a written agreement with the manufacturers" that gives CPI permission to perform the tracking responsibilities. The agency believes that such an agreement will "eliminate...any confusion concerning who is responsible" for conducting recall and notification procedures.
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