21 CFR Chapter I Subchapter H – Medical Devices – Part 820 Quality System Regulation

Name: 21 CFR Chapter I Subchapter H – Medical Devices – Part 820 Quality System Regulation
Creator: Food and Drug Administration
Keywords: 21-cfr,actions,audits,definitions,design,design-control,distribution,identification,inspection,labeling,medical-devices,packaging,provisions,quality,quality-systems,regulations,requirements,responsibilities,statistical,storage

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Regulation

Regulated products

Medical Devices

Last updated

June 4, 2024

Description

This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 820 Quality System Regulation".

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Food and Drug Administration (FDA) 🇺🇸

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United States

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15 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-820/subpart-A
Permalink: https://data.openrid.co/en/datasets/r/01b8a6d3-14b4-4056-9125-6d97754eb5c6
MIME Type: text/html

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

Scope. Definitions. Quality system.

Subpart B – Quality System Requirements

Updated on January 5, 2017

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URL: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820/subpart-B
Permalink: https://data.openrid.co/en/datasets/r/462fdea5-5f29-48b9-8395-bf8447d4e6f6
MIME Type: text/html

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

Management responsibility. Quality audit. Personnel.

Subpart C – Design Controls

Updated on June 4, 2024

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URL: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820/subpart-C
Permalink: https://data.openrid.co/en/datasets/r/69c26c9d-5d8b-4cf1-bccc-5bdea54fa69a
MIME Type: text/html

Created on: February 6, 2024
Modified on: June 4, 2024

Design controls.

Subpart D – Document Controls

Updated on January 5, 2017

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URL: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820/subpart-D
Permalink: https://data.openrid.co/en/datasets/r/b362b538-72a2-464c-87fe-40b0027e849c
MIME Type: text/html

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

Document controls.

Subpart E – Purchasing Controls

Updated on January 5, 2017

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URL: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820/subpart-E
Permalink: https://data.openrid.co/en/datasets/r/04769be0-1127-4ab7-bf3e-f0681ca55a47
MIME Type: text/html

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

Purchasing controls.

Subpart F – Identification and Traceability

Updated on January 5, 2017

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URL: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820/subpart-F
Permalink: https://data.openrid.co/en/datasets/r/713bef7b-7d60-45c0-8276-3d9b0d7b41ab
MIME Type: text/html

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

Identification. Traceability.

See the 15 main files

21 CFR Chapter I Subchapter H – Medical Devices – Part 820 Quality System Regulation

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