21 C.F.R. PART 3--PRODUCT JURISDICTION


TITLE 21--Food and Drugs

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER A--GENERAL

PART 3--PRODUCT JURISDICTION

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Subpart A--ASSIGNMENT OF AGENCY COMPONENT FOR REVIEW OF PREMARKET APPLICATIONS

�3.1
Purpose.
�3.2
Definitions.
�3.3
Scope.
�3.4
Designated agency component.
�3.5
Procedures for identifying the designated agency component.
�3.6
Product jurisdiction officer.
�3.7
Request for designation.
�3.8
Letter of designation.
�3.9
Effect of letter of designation.
�3.10
Stay of review time.
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Subpart B--[RESERVED]

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