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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
 
PART 821MEDICAL 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.

Authority: 21 U.S.C. 331, 351, 352, 360, 360e, 360h, 360i, 371, 374.
Source: 58 FR 43447, Aug. 16, 1993, unless otherwise noted.

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