TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL 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.
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Authority: 21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360i, 360j, 371, 374, 381, 393; 42 U.S.C. 264, 271.
Source: 42 FR 42526, Aug. 23, 1977, unless otherwise noted.
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