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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 807 - Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices |
Part 807 - Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
| Subpart A - General Provisions |
| § 807.3 - Definitions. |
| Subpart B - Procedures for Device Establishments |
| § 807.20 - Who must register and submit a device list? |
| § 807.21 - How to register establishments and list devices. |
| § 807.22 - Times for establishment registration and device listing. |
| § 807.25 - Information required for device establishment registration and device listing. |
| § 807.26 - Additional listing information. |
| § 807.28 - Updating device listing information. |
| § 807.30 - Updating device listing information. |
| § 807.31 - Additional listing information. |
| § 807.34 - Summary of requirements for owners or operators granted a waiver from submitting required information electronically. |
| § 807.35 - Notification of registrant. |
| § 807.37 - Public availability of establishment registration and device listing information. |
| § 807.39 - Misbranding by reference to establishment registration or to registration number. |
| Subpart C - Procedures for Foreign Device Establishments |
| § 807.40 - Establishment registration and device listing for foreign establishments importing or offering for import devices into the United States. |
| § 807.41 - Identification of importers and persons who import or offer for import. |
| Subpart D - Exemptions |
| § 807.65 - Exemptions for device establishments. |
| 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. |