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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21
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The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES
 
PART 807ESTABLISHMENT 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 - 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.

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.

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.

Authority: 21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360i, 360j, 360bbb-8b, 371, 374, 379k-1, 381, 393; 42 U.S.C. 264, 271.
Source: 42 FR 42526, Aug. 23, 1977, unless otherwise noted.

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