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SMG 1410.419

FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - MEDICAL DEVICES AND RADIOLOGICAL HEALTH

MEDICAL DEVICE USER FEE AUTHORITIES

Effective Date: 06/23/2009

[PDF Version]

1. AUTHORITY DELEGATED AND TO WHOM DELEGATED.

The Director, Deputy Directors, and Associate Director for Regulations and Policy, Center for Devices and Radiological Health (CDRH), the Director, Center for Biologics Evaluation and Research (CBER), for applications in their respective areas, are authorized to take actions necessary to implement and administer section 738 of the Federal Food, Drug, and Cosmetic Act, as added by the MDUFMA. This includes the authority to determine the kind of fee appropriate for a specific application, the authority to waive, adjust or refund medical device user fees for a specific application, and the authority to decide appeals of medical device user fee waiver decisions.

2. REDELEGATION.

This authority may be redelegated, in whole or in part. Any redelegation must be in writing and specify the nature and extent of the authority redelegated. Delegatees must be certified as knowledgeable about relevant legal, regulatory, and policy requirements. Each time a redelegation is made, a copy must be furnished to the FDA Delegations Officer (HFA-340). The authorities may also be exercised by anyone serving in an acting capacity to which authority has been delegated.

3. EFFECTIVE DATE.

This delegation was approved by the Commissioner on June 23, 2009

STATUS (I, R, C)DATE APPROVEDLOCATION OF CHANGE HISTORYCONTACTAPPROVING OFFICIAL
Initial06/23/2009N/aOC/OO/OM/OMPCommissioner of Food and Drugs