21 CFR Chapter I Subchapter H – Medical Devices – Part 800 General

Name: 21 CFR Chapter I Subchapter H – Medical Devices – Part 800 General
Creator: Food and Drug Administration
Keywords: 21-cfr,cdrh,center-for-devices-and-radiological-health,contacts,decisions,defects,detention,examination-gloves,hearing-aid,medical-devices,packaging,patients,practices,procedures,radiological,regulations,requests,requirements,review

Information

Original link

Type

Regulation

Regulated products

Medical Devices

Last updated

June 4, 2024

Description

21 CFR Chapter I Subchapter H - Medical Devices - Part 800 General: A regulation governing medical devices.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

Feedback

Suggest an improvement to this page

2 Main files

Subpart B – Requirements for Specific Medical Devices

Updated on June 4, 2024

html

URL: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-800/subpart-B
Permalink: https://data.openrid.co/en/datasets/r/2387f877-e5fb-49a2-adde-03f83cb3becb
MIME Type: text/html

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

Contact lens solutions; sterility. Contact lens solutions and tablets; tamper-resistant packaging. Patient examination gloves and surgeons' gloves; sample plans and test method for leakage defects; adulteration. Over-the-counter hearing aid controls.

Subpart C – Administrative Practices and Procedures

Updated on March 31, 2023

html

URL: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-800/subpart-C
Permalink: https://data.openrid.co/en/datasets/r/57085aa4-4891-445b-b1cb-9117f777d2a7
MIME Type: text/html

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

Administrative detention. Requests for supervisory review of certain decisions made by the Center for Devices and Radiological Health.