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Electronic Code of Federal Regulations

e-CFR data is current as of December 5, 2019

Title 21Chapter ISubchapter HPart 821


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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