Electronic Code of Federal Regulations

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e-CFR data is current as of January 21, 2021

Title 21 → Chapter I → Subchapter H → Part 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

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.

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