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Electronic Code of Federal Regulations

e-CFR data is current as of February 19, 2020

Title 21Chapter ISubchapter APart 3


TITLE 21—Food and Drugs

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

SUBCHAPTER A—GENERAL

PART 3—PRODUCT JURISDICTION

rule

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.
rule

Subpart B—[RESERVED]

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