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Title 21 - Title 21

Part 821 - MEDICAL DEVICE TRACKING REQUIREMENTS

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Details about Part 821

Description

MEDICAL DEVICES - MEDICAL DEVICE TRACKING REQUIREMENTS

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10 sections

§821.1 - Scope.

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§821.2 - Exemptions and variances.

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§821.20 - Devices subject to tracking.

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§821.25 - Device tracking system and content requirements: manufacturer requirements.

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§821.3 - Definitions.

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

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§821.4 - Imported devices.

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§821.50 - Availability.

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§821.55 - Confidentiality.

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§821.60 - Retention of records.

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