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
Subpart B--PROCEDURES FOR DEVICE ESTABLISHMENTS
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| Who must register and submit a device list?
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| Times for establishment registration and device listing.
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| How and where to register establishments and list devices.
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| Information required or requested for establishment registration and device listing.
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| Amendments to establishment registration.
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| Updating device listing information.
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| Additional listing information.
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| Notification of registrant.
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| Inspection of establishment registration and device listings.
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| Misbranding by reference to establishment registration or to registration number.
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Subpart C--REGISTRATION PROCEDURES FOR FOREIGN DEVICE ESTABLISHMENTS
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| Establishment registration and device listing for foreign establishments importing or offering for import devices into the United States.
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Subpart D--EXEMPTIONS
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| Exemptions for device establishments.
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Subpart E--PREMARKET NOTIFICATION PROCEDURES
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| When a premarket notification submission is required.
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| Exemption from premarket notification.
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| Information required in a premarket notification submission.
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| Format of a premarket notification submission.
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| Content and format of a 510(k) summary.
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| Content and format of a 510(k) statement.
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| Format of a class III certification.
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| Confidentiality of information.
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| Misbranding by reference to premarket notification.
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| FDA action on a premarket notification.
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