Title 21--Food and Drugs

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

PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND DISTRIBUTORS OF DEVICES

TEXT PDF807.3 Definitions.
TEXT PDF807.20 Who must register and submit a device list.
TEXT PDF807.21 Times for establishment registration and device listing.
TEXT PDF807.22 How and where to register establishments and list devices.
TEXT PDF807.25 Information required or requested for establishment registration and device listing.
TEXT PDF807.26 Amendments to establishment registration.
TEXT PDF807.30 Updating device listing information.
TEXT PDF807.31 Additional listing information.
TEXT PDF807.35 Notification of registrant.
TEXT PDF807.37 Inspection of establishment registration and device listings.
TEXT PDF807.39 Misbranding by reference to establishment registration or to registration number.
TEXT PDF807.40 Establishment registration and device listing for U.S. agents of foreign manufacturers of devices.
TEXT PDF807.65 Exemptions for device establishments.
TEXT PDF807.81 When a premarket notification submission is required.
TEXT PDF807.85 Exemption from premarket notification.
TEXT PDF807.87 Information required in a premarket notification submission.
TEXT PDF807.90 Format of a premarket notification submission.
TEXT PDF807.92 Content and format of a 510(k) summary.
TEXT PDF807.93 Content and format of a 510(k) statement.
TEXT PDF807.94 Format of a class III certification.
TEXT PDF807.95 Confidentiality of information.
TEXT PDF807.97 Misbranding by reference to premarket notification.
TEXT PDF807.100 FDA action on a premarket notification.

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