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U.S. Code of Federal Regula...
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Title 21-Food and Drugs
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CHAPTER I—FOOD AND DRUG ADM...
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PART 821—MEDICAL DEVICE TRACKING REQUIREMENTS
PART 821—MEDICAL DEVICE TRACKING REQUIREMENTS
§ 821.1 - Scope.
§ 821.2 - Exemptions and variances.
§ 821.3 - Definitions.
§ 821.4 - Imported devices.
§ 821.20 - Devices subject to tracking.
§ 821.25 - Device tracking system and content requirements: manufacturer requirements.
§ 821.30 - Tracking obligations of persons other than device manufacturers: distributor requirements.
§ 821.50 - Availability.
§ 821.55 - Confidentiality.
§ 821.60 - Retention of records.