21 CFR Chapter I Subchapter H – Medical Devices – Part 821 Medical Device Tracking Requirements

Name: 21 CFR Chapter I Subchapter H – Medical Devices – Part 821 Medical Device Tracking Requirements
Creator: Food and Drug Administration
Keywords: 21-cfr,availability,definitions,distributors,exemptions,import,inspection,manufacturers,medical-devices,obligations,provisions,regulations,requirements,responsibilities,tracking,variance

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Original link

Type

Regulation

Regulated products

Medical Devices

Last updated

March 31, 2023

Description

This document is a regulation titled "Medical Device Tracking Requirements" under 21 CFR Chapter I Subchapter H.

Organization

Food and Drug Administration (FDA) 🇺🇸

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United States

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Other (Public Domain)

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4 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-821/subpart-A
Permalink: https://data.openrid.co/en/datasets/r/0a39c980-38ac-427a-9571-d437459044c6
MIME Type: text/html

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

Scope. Exemptions and variances. Definitions. Imported devices.

Subpart B – Tracking Requirements

Updated on December 11, 2018

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URL: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-821/subpart-B
Permalink: https://data.openrid.co/en/datasets/r/88c873b5-fd28-4789-9832-1003a6966e12
MIME Type: text/html

Created on: February 6, 2024
Modified on: December 11, 2018

Devices subject to tracking. Device tracking system and content requirements: manufacturer requirements.

Subpart C – Additional Requirements and Responsibilities

Updated on January 5, 2017

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URL: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-821/subpart-C
Permalink: https://data.openrid.co/en/datasets/r/72473c1b-cc62-4828-9b49-171bcf90a9d0
MIME Type: text/html

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

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

Subpart D – Records and Inspections

Updated on January 5, 2017

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URL: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-821/subpart-D
Permalink: https://data.openrid.co/en/datasets/r/73541b5c-c707-4913-9453-0ce55e68927b
MIME Type: text/html

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

Availability. Confidentiality. Retention of records.

21 CFR Chapter I Subchapter H – Medical Devices – Part 821 Medical Device Tracking Requirements

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