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Title 21
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Part 807
FEDERAL · 21 CFR
Part 807 — Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
24 sections · Title 21: Food and Drugs
§ 807.3
Definitions.
§ 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.
§ 807.34
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.
§ 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.
§ 807.65
Exemptions for device establishments.
§ 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.