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Device surveillance office

This article was originally published in The Gray Sheet

Executive Summary

Becomes operational June 28 following approval by FDA Commissioner David Kessler the week of June 21. The new office of surveillance and biometrics (formerly referred to as the postmarket management office) is being led by Jane Arrowsmith- Lowe, who was previously a medical officer in the FDA drug center's division of antiviral drug products. In addition to the director's office, OSB is comprised of an "issues management staff" and three divisions: the division of surveillance systems, the division of postmarket clinical evaluation, and the division of biometric sciences. As anticipated, most of OSB's personnel come from the device center's office of compliance and surveillance and office of science and technology ("The Gray Sheet" May 24, p. 6). Concurrent with formation of the new office, OCS has been renamed the office of compliance.
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