21 C.F.R. PART 821--MEDICAL DEVICE TRACKING REQUIREMENTS

TITLE 21--Food and Drugs

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

SUBCHAPTER H--MEDICAL DEVICES

PART 821--MEDICAL DEVICE TRACKING REQUIREMENTS

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Subpart A--GENERAL PROVISIONS

§821.1
Scope.
§821.2
Exemptions and variances.
§821.3
Definitions.
§821.4
Imported devices.
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Subpart B--TRACKING REQUIREMENTS

§821.20
Devices subject to tracking.
§821.25
Device tracking system and content requirements: manufacturer requirements.
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Subpart C--ADDITIONAL REQUIREMENTS AND RESPONSIBILITIES

§821.30
Tracking obligations of persons other than device manufacturers: distributor requirements.
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Subpart D--RECORDS AND INSPECTIONS

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