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Title 21 → Chapter I → Subchapter H → Part 814

TITLE 21—Food and Drugs

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

SUBCHAPTER H—MEDICAL DEVICES

PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES

rule

Subpart A—GENERAL

§814.1
Scope.
§814.2
Purpose.
§814.3
Definitions.
§814.9
Confidentiality of data and information in a premarket approval application (PMA) file.
§814.15
Research conducted outside the United States.
§814.17
Service of orders.
§814.19
Product development protocol (PDP).
rule

Subpart B—PREMARKET APPROVAL APPLICATION (PMA)

§814.20
Application.
§814.37
PMA amendments and resubmitted PMAs.
§814.39
PMA supplements.
rule

Subpart C—FDA ACTION ON A PMA

§814.40
Time frames for reviewing a PMA.
§814.42
Filing a PMA.
§814.44
Procedures for review of a PMA.
§814.45
Denial of approval of a PMA.
§814.46
Withdrawal of approval of a PMA.
§814.47
Temporary suspension of approval of a PMA.
rule

Subpart D—ADMINISTRATIVE REVIEW [RESERVED]

rule

Subpart E—POSTAPPROVAL REQUIREMENTS

§814.80
General.
§814.82
Postapproval requirements.
§814.84
Reports.
rule

Subparts F-G [Reserved]

rule

Subpart H—HUMANITARIAN USE DEVICES

§814.100
Purpose and scope.
§814.102
Designation of HUD status.
§814.104
Original applications.
§814.106
HDE amendments and resubmitted HDE's.
§814.108
Supplemental applications.
§814.110
New indications for use.
§814.112
Filing an HDE.
§814.114
Timeframes for reviewing an HDE.
§814.116
Procedures for review of an HDE.
§814.118
Denial of approval or withdrawal of approval of an HDE.
§814.120
Temporary suspension of approval of an HDE.
§814.122
Confidentiality of data and information.
§814.124
Institutional Review Board requirements.
§814.126
Postapproval requirements and reports.

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