21 CFR Chapter I Subchapter H – Medical Devices – Part 830 Unique Device Identification

Name: 21 CFR Chapter I Subchapter H – Medical Devices – Part 830 Unique Device Identification
Creator: Food and Drug Administration
Keywords: 21-cfr,accreditation,applications,changes,corrections,data,databases,definitions,fda,identification,medical-devices,provisions,regulations,requirements,responsibilities,submissions,udi,unique-device-identification,unique-device-identifier

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Regulation

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Medical Devices

Last updated

July 17, 2023

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This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 830 Unique Device Identification".

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Food and Drug Administration (FDA) 🇺🇸

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United States

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5 Main files

Subpart A – General Provisions

Updated on March 31, 2023

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URL: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-830/subpart-A
Permalink: https://data.openrid.co/en/datasets/r/13a8375c-3b50-4a71-9b40-e210b79d4938
MIME Type: text/html

Created on: February 6, 2024
Modified on: March 31, 2023

Definitions.

Subpart B – Requirements for a Unique Device Identifier

Updated on July 17, 2023

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URL: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-830/subpart-B
Permalink: https://data.openrid.co/en/datasets/r/6a6b44f2-5057-499a-85a3-76c87edf745e
MIME Type: text/html

Created on: February 6, 2024
Modified on: July 17, 2023

Incorporation by reference. Requirements for a unique device identifier. Use and discontinuation of a device identifier. Changes that require use of a new device identifier. Relabeling of a device that is required to bear a unique device identifier.

Subpart C – FDA Accreditation of an Issuing Agency

Updated on April 17, 2020

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URL: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-830/subpart-C
Permalink: https://data.openrid.co/en/datasets/r/93eba4cc-85c0-4d7e-857f-0d19c995b2a7
MIME Type: text/html

Created on: February 6, 2024
Modified on: April 17, 2020

FDA accreditation of an issuing agency. Application for accreditation as an issuing agency. Responsibilities of an FDA-accredited issuing agency. Suspension or revocation of the accreditation of an issuing agency.

Subpart D – FDA as an Issuing Agency

Updated on January 5, 2017

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URL: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-830/subpart-D
Permalink: https://data.openrid.co/en/datasets/r/e7c41439-4096-4d26-9e26-f053fccace20
MIME Type: text/html

Created on: February 6, 2024
Modified on: January 5, 2017

When FDA will act as an issuing agency. Eligibility for use of FDA as an issuing agency. Termination of FDA service as an issuing agency.

Subpart E – Global Unique Device Identification Database

Updated on April 17, 2020

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URL: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-830/subpart-E
Permalink: https://data.openrid.co/en/datasets/r/82ce5d19-d437-42c1-b75a-4e2321308982
MIME Type: text/html

Created on: February 6, 2024
Modified on: April 17, 2020

Devices subject to device identification data submission requirements. Information required for unique device identification. Submission of unique device identification information. Times for submission of unique device identification information. Voluntary submission of ancillary device identification information. Correction of information submitted to the Global Unique Device Identification Database. Records to be maintained by the labeler.

21 CFR Chapter I Subchapter H – Medical Devices – Part 830 Unique Device Identification

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