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FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - MEDICAL DEVICES AND RADIOLOGICAL HEALTH

SMG 1410.401 - ISSUANCE OF FEDERAL REGISTER DOCUMENTS TO RECOGNIZE OR TO WITHDRAW RECOGNITION OF A STANDARD TO MEET PREMARKET SUBMISSION REQUIREMENTS

1. AUTHORITY DELEGATED AND TO WHOM DELEGATED.

The Director and Deputy Director, Center for Devices and Radiological Health; Director and Deputy Directors, Center for Biologics Evaluation and Research, and the Director and Deputy Director, Center for Drug Evaluation and Research,are authorized to issue Federal Register documents under section 514(c) of the Federal Food, Drug and Cosmetic Act (the act) (21 U.S.C. 360d(c)) recognizing or withdrawing recognition of a standard for which a person may submit a declaration of conformity in order to meet a premarket submission requirement.

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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