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Code of Federal Regulations (Last Updated: April 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 814 - Premarket 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 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 |
| Subpart E - Postapproval Requirements |
| § 814.80 - General. |
| § 814.82 - Postapproval requirements. |
| § 814.84 - Reports. |
| Subparts F--G - XXX |
| 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. |