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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

Subpart A--GENERAL PROVISIONS

�821.1

Scope.

�821.2

Exemptions and variances.

�821.3

Definitions.

�821.4

Imported devices.

Subpart B--TRACKING REQUIREMENTS

�821.20

Devices subject to tracking.

�821.25

Device tracking system and content requirements: manufacturer requirements.

Subpart C--ADDITIONAL REQUIREMENTS AND RESPONSIBILITIES

�821.30

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

Subpart D--RECORDS AND INSPECTIONS

�821.50

Availability.

�821.55

Confidentiality.

�821.60

Retention of records.