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FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - MEDICAL DEVICES AND RADIOLOGICAL HEALTH

1410.417 - MEDICAL DEVICE TRACKING

1. AUTHORITY DELEGATED AND TO WHOM DELEGATED.

The following officials are authorized to issue orders under section 519(e) of the Federal Food Drug and Cosmetic Act (21 U.S.C. 360i(e)) requiring manufacturers to adopt methods of tracking devices:

1. The Director and Deputy Director, Center for Devices and Radiological Health (CDRH).

2. The Director and Deputy Director, Office of Compliance, CDRH.

3. The Director and Deputy Director, Office of In Vitro Diagnostic Devices Evaluation and Safety, CDRH.

2. REDELEGATION.

These officials may not further redelegate this authority.

3. EFFECTIVE DATE.

This delegation was approved on April 14, 2003.

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