21 CFR Part 814
PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES
- PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter H—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 PMAs.
- § 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.
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