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Code of Federal Regulations (Last Updated: November 8, 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 807 - Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices |
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Subpart E - Premarket Notification Procedures |
| § 807.81 - When a premarket notification submission is required. |
| § 807.85 - Exemption from premarket notification. |
| § 807.87 - Information required in a premarket notification submission. |
| § 807.90 - Format of a premarket notification submission. |
| § 807.92 - Content and format of a 510(k) summary. |
| § 807.93 - Content and format of a 510(k) statement. |
| § 807.94 - Format of a class III certification. |
| § 807.95 - Confidentiality of information. |
| § 807.97 - Misbranding by reference to premarket notification. |
| § 807.100 - FDA action on a premarket notification. |