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The Electronic Code of Federal Regulations (e-CFR) is a regularly updated, unofficial editorial compilation of CFR material and Federal Register amendments produced by the National Archives and Records Administration's Office of the Federal Register (OFR) and the Government Printing Office.

Parallel Table of Authorities and Rules for the Code of Federal Regulations and the United States Code
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Electronic Code of Federal Regulations

blue pill

e-CFR Data is current as of April 22, 2014

TITLE 21—Food and Drugs

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

SUBCHAPTER H—MEDICAL DEVICES

PART 821—MEDICAL DEVICE TRACKING REQUIREMENTS

rule

Subpart A—GENERAL PROVISIONS

§821.1
Scope.
§821.2
Exemptions and variances.
§821.3
Definitions.
§821.4
Imported devices.
rule

Subpart B—TRACKING REQUIREMENTS

§821.20
Devices subject to tracking.
§821.25
Device tracking system and content requirements: manufacturer requirements.
rule

Subpart C—ADDITIONAL REQUIREMENTS AND RESPONSIBILITIES

§821.30
Tracking obligations of persons other than device manufacturers: distributor requirements.
rule

Subpart D—RECORDS AND INSPECTIONS

§821.50
Availability.
§821.55
Confidentiality.
§821.60
Retention of records.


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