21CFR830.50

§ 830.50 Changes that require use of a new device identifier.

Regulation Text

(a) Whenever you make a change to a device that is required to bear a unique device identifier (UDI) on its label, and the change results in a new version or model, you must assign a new device identifier to the new version or model. (b) Whenever you create a new device package, you must assign a new device identifier to the new device package.

Authority

21 U.S.C. 321,331,352,353,360,360d,360i,360j,371.

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Related Guidelines (7)

Unique Device Identifier System: Frequently Asked Questions, Vol. 1 : Guidance for Industry and Food and Drug Administration Staff (Status: Final)
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Unique Device Identification: Direct Marking of Devices : Guidance for Industry and Food and Drug Administration Staff (Status: Final)
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Global Unique Device Identification Database (GUDID): Guidance for Industry and Food and Drug Administration Staff (Status: Final)
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Unique Device Identification: Convenience Kits : Guidance for Industry and Food and Drug Administration Staff (Status: Final)
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Predetermined Change Control Plans for Medical Devices: Draft Guidance for Industry and FDA Staff (Status: Draft)
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Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
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Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
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21CFR830.50 — § 830.50 Changes that require use of a new device identifier. | CFR Explorer | BioRegHub