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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
 
PART 814PREMARKET APPROVAL OF MEDICAL DEVICES
 

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).

Subpart B--Premarket Approval Application (PMA)
   § 814.20 - Application.
   § 814.37 - PMA amendments and resubmitted PMA's.
   § 814.39 - PMA supplements.

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.

Subpart D--Administrative Review [Reserved]

Subpart E--Postapproval Requirements
   § 814.80 - General.
   § 814.82 - Postapproval requirements.
   § 814.84 - Reports.

Subparts F-G [Reserved]

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.

Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 371, 372, 373, 374, 375, 379, 379e, 381.
Source: 51 FR 26364, July 22, 1986, unless otherwise noted.

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