21 CFR Chapter I Subchapter H – Medical Devices – Part 860 Medical Device Classification Procedures

Name: 21 CFR Chapter I Subchapter H – Medical Devices – Part 860 Medical Device Classification Procedures
Creator: Food and Drug Administration
Keywords: 21-cfr,approval,classification,consultations,cosmetics,data,definitions,device-classification,drugs,effectiveness,exemptions,forms,implants,medical-devices,performance,petitions,pre-market,pre-market-approval,procedures,reclassification,regulations,requests,review,safety,standards,withdrawal

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Regulation

Regulated products

Medical Devices

Last updated

July 17, 2023

Description

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

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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

Updated on July 17, 2023

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URL: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-860/subpart-A
Permalink: https://data.openrid.co/en/datasets/r/f9702b01-c87b-48ec-a409-1d1512f96bde
MIME Type: text/html

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

Scope. Definitions. Confidentiality and use of data and information submitted in connection with classification and reclassification. Determination of safety and effectiveness. Implants and life-supporting or life-sustaining devices. Exemptions from sections 510, 519, and 520(f) of the Federal Food, Drug, and Cosmetic Act.

Subpart B – Classification

Updated on January 6, 2022

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URL: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-860/subpart-B
Permalink: https://data.openrid.co/en/datasets/r/c594afba-e091-438f-93ae-186de797d5e0
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Created on: February 6, 2024
Modified on: January 6, 2022

Classification procedures for “preamendments devices.” Consultation with panels.

Subpart C – Reclassification

Updated on January 6, 2022

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URL: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-860/subpart-C
Permalink: https://data.openrid.co/en/datasets/r/157566a2-a38a-4087-9521-6d6fd52f1316
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Created on: February 6, 2024
Modified on: January 6, 2022

General. Reclassification petition: Content and form. Consultation with panels. General procedures under section 513(e) of the Federal Food, Drug, and Cosmetic Act. Procedures when the Commissioner initiates a performance standard or premarket approval proceeding under section 514(b) or 515(b) of the Federal Food, Drug, and Cosmetic Act. Procedures when the Commissioner initiates a proceeding to require premarket approval under section 515(b) of the Federal Food, Drug, and Cosmetic Act. Procedures for reclassification of “postamendments devices” under section 513(f)(3) of the Federal Food, Drug, and Cosmetic Act. Procedures for transitional products under section 520(l) of the Federal Food, Drug, and Cosmetic Act.

Subpart D – De Novo Classification

Updated on January 6, 2022

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URL: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-860/subpart-D
Permalink: https://data.openrid.co/en/datasets/r/61c50cff-d042-43b5-8da9-2a940035f2a9
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Created on: February 6, 2024
Modified on: January 6, 2022

Purpose and applicability. De Novo request format. De Novo request content. Accepting a De Novo request. Procedures for review of a De Novo request. Withdrawal of a De Novo request. Granting or declining a De Novo request.

21 CFR Chapter I Subchapter H – Medical Devices – Part 860 Medical Device Classification Procedures

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