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21 C.F.R. PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES

TITLE 21--Food and Drugs

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H--MEDICAL 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

Times for establishment registration and device listing.

�807.22

How and where to register establishments and list devices.

�807.25

Information required or requested for establishment registration and device listing.

�807.26

Amendments to establishment registration.

�807.30

Updating device listing information.

�807.31

Additional listing information.

�807.35

Notification of registrant.

�807.37

Inspection of establishment registration and device listings.

�807.39

Misbranding by reference to establishment registration or to registration number.

Subpart C--REGISTRATION 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.

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.