21 C.F.R. · Food and Drugs
21 C.F.R. § 830.50

Changes that require use of a new device identifier.

Title 21 C.F.R. ● ACTIVE Primary Source
Regulatory Text

21 C.F.R. § 830.50 — Changes that require use of a new device identifier.

§ 830.50 Changes that require use of a new device identifier. (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. [78 FR 58825, Sept. 24, 2013]

Source: ecfr.gov · govinfo.gov — public domain Official Source ↗
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21 C.F.R. § 830.50
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The regulatory text of 21 C.F.R. § 830.50 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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