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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 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. |