§ 5.401 - Issuance of Federal Register documents pertaining to exemptions from premarket notification.

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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 Directors and Deputy Directors, Center for Biologics Evaluation and Research, are authorized to make determinations and issue Federal Register notices and rules under section 510(m) of the act (21 U.S.C. 360(m)) concerning exemptions from premarket notification.

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

                    
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