§ 5.400 - Issuance of Federal Register documents to recognize or to withdraw recognition of a standard to meet premarket submission requirements.

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(a) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health; and the Director and Deputy Directors, Center for Biologics 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.

(b) These officials may not further redelegate this authority.

                    
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