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Title 21 - Title 21

Part 807 - ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES

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Details about Part 807

Description

MEDICAL DEVICES - ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES

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24 sections

§807.100 - FDA action on a premarket notification.

Title 21, Part 807

§807.20 - Who must register and submit a device list?

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§807.21 - How to register establishments and list devices.

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§807.22 - Times for establishment registration and device listing.

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§807.25 - Information required for device establishment registration and device listing.

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§807.26 - Additional listing information.

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§807.28 - Updating device listing information.

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§807.3 - Definitions.

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§807.34 - Summary of requirements for owners or operators granted a waiver from submitting required information electronically.

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§807.35 - Notification of registrant.

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§807.37 - Public availability of establishment registration and device listing information.

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§807.39 - Misbranding by reference to establishment registration or to registration number.

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§807.40 - Establishment registration and device listing for foreign establishments importing or offering for import devices into the United States.

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§807.41 - Identification of importers and persons who import or offer for import.

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§807.65 - Exemptions for device establishments.

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§807.81 - When a premarket notification submission is required.

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§807.85 - Exemption from premarket notification.

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§807.87 - Information required in a premarket notification submission.

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§807.90 - Format of a premarket notification submission.

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§807.92 - Content and format of a 510(k) summary.

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§807.93 - Content and format of a 510(k) statement.

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§807.94 - Format of a class III certification.

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§807.95 - Confidentiality of information.

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§807.97 - Misbranding by reference to premarket notification.

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