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FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - MEDICAL DEVICES AND RADIOLOGICAL HEALTH

1410.416 - AUTHORITY RELATING TO MEDICAL DEVICE REPORTING PROCEDURES

1. AUTHORITIES DELEGATED AND TO WHOM DELEGATED.

A. The Director and Deputy Director, Center for Devices and Radiological Health (CDRH), the Director and Deputy Director, Office of Surveillance and Biometrics (OSB), CDRH, and the Director and Deputy Director, Division of Surveillance Systems (DSS), OSB, CDRH, are authorized to approve electronic reporting under 21 CFR, Part 800, section 803.14.

B. The Director and Deputy Directors for Science and for Regulations and Policy, CDRH, the Director and Deputy Director, OSB, CDRH, the Director and Deputy Director, DSS, OSB, CDRH, and the Director, IMS, OSB, CDRH are authorized to request the submission of additional information under 21 CFR, Part 800 section, 803.15.

C. The Director and Deputy Directors for Science and for Regulations and Policy, CDRH, the Director and Deputy Director, OSB, CDRH, and the Director and Deputy Director, DSS, OSB, CDRH are authorized to grant or revoke exemptions and variances from reporting requirements under 21 CFR, Part 800, Section 803.19.

2. REDELEGATION.

These officials may not further redelegate these authorities.

3. EFFECTIVE DATE.

This delegation was signed by the Commissioner on August 24, 2007.

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