21 CFR Chapter I Subchapter H – Medical Devices – Part 812 Investigational Device Exemptions

Name: 21 CFR Chapter I Subchapter H – Medical Devices – Part 812 Investigational Device Exemptions
Creator: Food and Drug Administration
Keywords: 21-cfr,actions,applications,approval,clinical-investigation,clinical-investigators,data,definitions,disqualification,emergency,exemptions,export,fda,import,inspection,investigation,investigational-device-exemption,investigational-devices,labeling,medical-devices,monitoring,practices,provisions,regulations,reporting,requirements,research,responsibilities,review,risks,significant-risk,sponsors,treatment,waiver

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Regulation

Regulated products

Medical Devices

Last updated

January 23, 2024

Description

Regulation on Investigational Device Exemptions under 21 CFR Chapter I Subchapter H - Medical Devices - Part 812.

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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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6 Main files

Subpart A – General Provisions

Updated on January 23, 2024

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URL: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-812/subpart-A
Permalink: https://data.openrid.co/en/datasets/r/255ee36b-0cd0-4d37-b84f-22724646ca55
MIME Type: text/html

Created on: February 6, 2024
Modified on: January 23, 2024

Scope. Applicability. Definitions. Labeling of investigational devices. Prohibition of promotion and other practices. Waivers. Import and export requirements. Address for IDE correspondence.

Subpart B – Application and Administrative Action

Updated on March 31, 2023

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URL: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-812/subpart-B
Permalink: https://data.openrid.co/en/datasets/r/d9c0d626-a3b7-4f1f-8d44-6db1b4b5f987
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Created on: February 6, 2024
Modified on: March 31, 2023

Application. Investigational plan. Report of prior investigations. Acceptance of data from clinical investigations conducted outside the United States. FDA action on applications. Supplemental applications. Treatment use of an investigational device. Confidentiality of data and information.

Subpart C – Responsibilities of Sponsors

Updated on March 22, 2023

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URL: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-812/subpart-C
Permalink: https://data.openrid.co/en/datasets/r/6f99069c-a923-452d-b51f-f421743f15fb
MIME Type: text/html

Created on: February 6, 2024
Modified on: March 22, 2023

General responsibilities of sponsors. FDA and IRB approval. Selecting investigators and monitors. Informing investigators. Monitoring investigations. Emergency research under § 50.24 of this chapter.

Subpart D – IRB Review and Approval

Updated on January 5, 2017

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URL: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-812/subpart-D
Permalink: https://data.openrid.co/en/datasets/r/5fb07467-b26a-46d1-b3cc-009fbe692de0
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Created on: February 6, 2024
Modified on: January 5, 2017

IRB composition, duties, and functions. IRB approval. IRB's continuing review. § 812.65 [Reserved] Significant risk device determinations.

Subpart E – Responsibilities of Investigators

Updated on January 5, 2017

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URL: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-812/subpart-E
Permalink: https://data.openrid.co/en/datasets/r/ff557236-3626-429d-bb24-d7d7c5f9b0ee
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Created on: February 6, 2024
Modified on: January 5, 2017

General responsibilities of investigators. Specific responsibilities of investigators. Disqualification of a clinical investigator.

Subpart G – Records and Reports

Updated on March 8, 2019

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URL: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-812/subpart-G
Permalink: https://data.openrid.co/en/datasets/r/6205ba36-1831-46e9-ad68-c1a8f276e94e
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Created on: February 6, 2024
Modified on: March 8, 2019

Records. Inspections. Reports.

21 CFR Chapter I Subchapter H – Medical Devices – Part 812 Investigational Device Exemptions

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