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Electronic Code of Federal Regulations

e-CFR data is current as of December 12, 2019

Title 21Chapter ISubchapter HPart 807


TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER H—MEDICAL DEVICES

PART 807—ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES

rule

Subpart A—GENERAL PROVISIONS

§807.3
Definitions.
rule

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.
§807.34
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.
rule

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.
rule

Subpart D—EXEMPTIONS

§807.65
Exemptions for device establishments.
rule

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.

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