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FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - MEDICAL DEVICES AND RADIOLOGICAL HEALTH

SMG 1410.402 - ISSUANCE OF FEDERAL REGISTER DOCUMENTS PERTAINING TO PREMARKET SUBMISSION REQUIREMENTS AND EXEMPTION FROM PREMARKET NOTIFICATION

1. AUTHORITY DELEGATED AND TO WHOM DELEGATED.

The Director and Deputy Director, Center for Devices and Radiological Health; the Directors and Deputy Directors, Center for Biologics Evaluation and Research, and the Director and Deputy Director, Center for Drug Evaluation and Research, are authorized to make determinations and issue Federal Register notices and rules under Sec. 510(m) of the Federal Food Drug and Cosmetic Act (21 U.S.C. 360(m)) concerning exemptions from premarket notification.

2. REDELEGATION.

These officials may not further redelegate this authority.

3. EFFECTIVE DATE.

This delegation was signed by the Commissioner on June 27, 2003.

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