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1. AUTHORITY DELEGATED AND TO WHOM DELEGATED.
The Director, Center for Devices and Radiological Health (CDRH) and 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 authoritiy 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 Delegatons 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 on June 18, 2003.