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1. AUTHORITY DELEGATED AND TO WHOM DELEGATED.
A. The following officials are authorized to provide, in response to a written request pursuant to section 513(g) of the act, a written statement of the classification (if any) of a device and the requirements of the act applicable to the device.
1. The Director, Deputy Director, and Associate Director for Regulations and Policy, Center for Devices and Radiological Health (CDRH).
2. The Director, Deputy Directors, Director Program Operations Staff (POS), and Director 510(k) Staff (POS), Office of Device Evaluation, and the Director and Deputy Director, Office of In Vitro Diagnostic Devices Evaluation and Safety, CDRH.
3. The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER), and the Director and Deputy Directors of the Office of Blood Research and Review (OBRR), the Office of Vaccines Research and Review (OVRR), and the Office of Cellular, Tissue and Gene Therapies, CBER.
2. REDELEGATION.
These officials may not further redelegate these authorities. Authority delegated to a position by title may be exercised by a person officially designated to serve in that position in an acting capacity or on a temporary basis, unless prohibited by a restriction in the document designating him/her “acting” or unless not legally permissible.
3. EFFECTIVE DATE.
This delegation was signed by the Commissioner on June 6, 2008.