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Code of Federal Regulations (Last Updated: October 10, 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 |
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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). |