Document:USA 21 CFR Part 812 09-Apr-2025
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| Document information | |
|---|---|
| Reference | USA 21 CFR Part 812 09-Apr-2025 |
| Validity area | USA |
| Scope(s) | MD |
| Document name | 21 CFR Part 812 |
| Version / Revision | 09-Apr-2025 |
| Status | Current |
| Document type | Legal act |
| Language(s) | EN |
| Description | Title 21 โFood and Drugs
Chapter I โFood and Drug Administration, Department of Health and Human Services Subchapter HโMedical Devices Part 812 Investigational Device Exemptions https://www.ecfr.gov/current/title-21 |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
References
| Reference | Scope | Document part | Language | Preview |
|---|---|---|---|---|
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.1 | MD | ยง 812.1 | EN | ยง 812.1 Scope. (a) [โฆ] This part provides procedures for the conduct of clinical investigations of devices. An approved investigational device exemption (IDE) permits a device that otherwise would be ... |
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.3 (f) | MD | ยง 812.3
(f) || EN || (f) Institutional review board (IRB) means any board, committee, or other group formally designated by an institution to review biomedical research involving subjects and established, operated, and ... | ||
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.3 (t) | MD | ยง 812.3
(t) || EN || (t) Independent ethics committee (IEC) means an independent review panel that is responsible for ensuring the protection of the rights, safety, and well-being of subjects involved in a clinical ... | ||
| Reference:USA 21 CFR Part 812 09-Apr-2025 Subpart B | MD | Subpart B | EN | Subpart BโApplication and Administrative Action ยง 812.20 Application. (a) Submission. [โฆ] (b) Contents [โฆ] |
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.30 | MD | ยง 812.30 | EN | ยง 812.30 FDA action on applications (a) Approval or disapproval. FDA will notify the sponsor in writing of the date it receives an application. FDA may approve an investigation as proposed, approve ... |
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.42 | MD | ยง 812.42 | EN | ยง 812.42 FDA and IRB approval. A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both approved the application or supplemental application relating to ... |
| Reference:USA 21 CFR Part 812 09-Apr-2025 Subpart D | MD | Subpart D | EN | Subpart DโIRB Review and Approval ยง 812.60 IRB composition, duties, and functions. An IRB reviewing and approving investigations under this part shall comply with the requirements of part 56 in all ... |
| Reference:USA 21 CFR Part 812 09-Apr-2025 Subpart G | MD | Subpart G | EN | Subpart GโRecords and Reports ยง 812.140 Records. (a) Investigator records. A participating investigator shall maintain the following accurate, complete, and current records relating to the ... |
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.25 | MD | ยง 812.25 | EN | ยง 812.25 Investigational plan. The investigational plan shall include, in the following order: (a) Purpose. The name and intended use of the device and the objectives and duration of the ... |
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.27 | MD | ยง 812.27 | EN | ยง 812.27 Report of prior investigations. (a) General. The report of prior investigations shall include reports of all prior clinical, animal, and laboratory testing of the device and shall be ... |
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.3 (n) | MD | ยง 812.3
(n) || EN || (n) Sponsor means a person who initiates, but who does not actually conduct, the investigation, that is, the investigational device is administered, dispensed, or used under the immediate direction ... | ||
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.3 (o) | MD | ยง 812.3
(o) || EN || (o) Sponsor-investigator means an individual who both initiates and actually conducts, alone or with others, an investigation, that is, under whose immediate direction the investigational device is ... | ||
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.40 | MD | ยง 812.40 | EN | ยง 812.40 General responsibilities of sponsors. Sponsors are responsible for selecting qualified investigators and providing them with the information they need to conduct the investigation properly, ... |
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.43 | MD | ยง 812.43 | EN | ยง 812.43 Selecting investigators and monitors. (a) Selecting investigators. [โฆ] (b) Control of device [โฆ] (c) Obtaining agreements [...] curriculum vitae [โฆ] investigator's relevant experience [โฆ] ... |
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.45 | MD | ยง 812.45 | EN | ยง 812.45 Informing investigators. A sponsor shall supply all investigators participating in the investigation with copies of the investigational plan and the report of prior investigations of the ... |
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.3 (e) | MD | ยง 812.3
(e) || EN || (e) Institution means a person, other than an individual, who engages in the conduct of research on subjects or in the delivery of medical services to individuals as a primary activity or as an ... | ||
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.3 (i) | MD | ยง 812.3
(i) || EN || (i) Investigator means an individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a ... | ||
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.43 (c) (4) | MD | ยง 812.43
(c) (4) || EN || ยง 812.43 Selecting investigators and monitors. [โฆ] (4) A statement of the investigator's commitment to: (i) Conduct the investigation in accordance with the agreement, the investigational plan, this ... | ||
| Reference:USA 21 CFR Part 812 09-Apr-2025 Subpart E | MD | Subpart E | EN | Subpart EโResponsibilities of Investigators ยง 812.100 General responsibilities of investigators. An investigator is responsible for ensuring that an investigation is conducted according to the signed ... |
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.43 (c) (5) | MD | ยง 812.43
(c) (5) || EN || ยง 812.43 Selecting investigators and monitors. (c) Obtaining agreements. A sponsor shall obtain from each participating investigator a signed agreement that includes: [โฆ] (5) Sufficient accurate ... | ||
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.100 | MD | ยง 812.100 | EN | ยง 812.100 General responsibilities of investigators. An investigator is responsible for ensuring that an investigation is conducted according to the signed agreement, the investigational plan and ... |
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.3 (p) | MD | ยง 812.3
(p) || EN || (p) Subject means a human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control. A subject may be in normal ... | ||
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.150 (a) (5) | MD | ยง 812.150
(a) (5) || EN || ยง 812.150 Reports. (a) Investigator reports. An investigator shall prepare and submit the following complete, accurate, and timely reports: (5) Informed consent. If an investigator uses a device ... | ||
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.150 (b) (8) | MD | ยง 812.150
(b) (8) || EN || ยง 812.150 Reports. (b) Sponsor reports [...] (8) Informed consent. A sponsor shall submit to FDA a copy of any report by an investigator under paragraph (a)(5) of this section of use of a device ... | ||
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.3 (g) | MD | ยง 812.3
(g) || EN || (g) Investigational device means a device, including a transitional device, that is the object of an investigation. | ||
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.3 (m) | MD | ยง 812.3
(m) || EN || (m) Significant risk device means an investigational device that: (1) Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject; (2) Is ... | ||
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.3 (r) | MD | ยง 812.3
(r) || EN || (r) Transitional device means a device subject to section 520(l) of the act, that is, a device that FDA considered to be a new drug or an antibiotic drug before May 28, 1976. | ||
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.110 (c) | MD | ยง 812.110
(c) || EN || ยง 812.110 Specific responsibilities of investigators. (c) Supervising device use. An investigator shall permit an investigational device to be used only with subjects under the investigator's ... | ||
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.140 (a) (2) | MD | ยง 812.140
(a) (2) || EN || ยง 812.140 Records. [โฆ] (a) Investigator records. A participating investigator shall maintain the following accurate, complete, and current records relating to the investigator's participation in an ... | ||
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.46 (a) | MD | ยง 812.46
(a) || EN || ยง 812.46 Monitoring investigations (a) Securing compliance. A sponsor who discovers that an investigator is not complying with the signed agreement, the investigational plan, the requirements of this ... | ||
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.110 (b) | MD | ยง 812.110
(b) || EN || ยง 812.110 Specific responsibilities of investigators. (b) Compliance. An investigator shall conduct an investigation in accordance with the signed agreement with the sponsor, the investigational ... | ||
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.119 | MD | ยง 812.119 | EN | ยง 812.119 Disqualification of a clinical investigator. [โฆ] |
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.140 (a) (3) | MD | ยง 812.140
(a) (3) || EN || ยง 812.140 Records. [โฆ] (a) Investigator records. A participating investigator shall maintain the following accurate, complete, and current records relating to the investigator's participation in an ... | ||
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.3 (j) | MD | ยง 812.3
(j) || EN || (j) Monitor, when used as a noun, means an individual designated by a sponsor or contract research organization to oversee the progress of an investigation. The monitor may be an employee of a ... | ||
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.35 | MD | ยง 812.35 | EN | ยง 812.35 Supplemental applications (a) Changes in investigational plan โ (1) Changes requiring prior approval [โฆ] (2) Changes effected for emergency use [โฆ] (3) Changes effected with notice to FDA ... |
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.145 | MD | ยง 812.145 | EN | ยง 812.145 Inspections (a) Entry and inspection. A sponsor or an investigator who has authority to grant access shall permit authorized FDA employees, at reasonable times and in a reasonable manner, ... |
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.3 (s) | MD | ยง 812.3
(s) || EN || (s) Unanticipated adverse device effect means any serious adverse effect on health or safety or any lifethreatening problem or death caused by, or associated with, a device, if that effect, problem, ... | ||
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.140 (a) (3) (ii) | MD | ยง 812.140
(a) (3) (ii) || EN || ยง 812.140 Records. (a) Investigator records. A participating investigator shall maintain the following accurate, complete, and current records relating to the investigator's participation in an ... | ||
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.150 (a) (1) | MD | ยง 812.150
(a) (1) || EN || ยง 812.150 Reports. (a) Investigator reports. An investigator shall prepare and submit the following complete, accurate, and timely reports: (1) Unanticipated adverse device effects. An investigator ... | ||
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.140 (b) (5) | MD | ยง 812.140
(b) (5) || EN || ยง 812.140 Records. [โฆ] (b) Sponsor records.[...] (5) Records concerning adverse device effects (whether anticipated or unanticipated) and complaints [...] | ||
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.150 (b) (1) | MD | ยง 812.150
(b) (1) || EN || ยง 812.150 Reports. (b) Sponsor reports. [...] (1) Unanticipated adverse device effects. A sponsor who conducts an evaluation of an unanticipated adverse device effect under ยง 812.46(b) shall report ... | ||
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.150 (a) (4) | MD | ยง 812.150
(a) (4) || EN || ยง 812.150 Reports. (a) Investigator reports. An investigator shall prepare and submit the following complete, accurate, and timely reports: (4) Deviations from the investigational plan. An ... | ||
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.46 (b) | MD | ยง 812.46
(b) || EN || ยง 812.46 Monitoring investigations [โฆ] (b) Unanticipated adverse device effects. (1) A sponsor shall immediately conduct an evaluation of any unanticipated adverse device effect. (2) A sponsor who ... | ||
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.7 (c) | MD | ยง 812.7
(c) || EN || ยง 812.7 Prohibition of promotion and other practices. A sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator shall not: [โฆ] (c) Unduly prolong an investigation. ... | ||
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.30 (b) - (c) | MD | ยง 812.30
(b) - (c) || EN || ยง 812.30 FDA action on applications [...] (b) Grounds for disapproval or withdrawal. FDA may disapprove or withdraw approval of an application if FDA finds that: (1) There has been a failure to ... | ||
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.46 (b) - (c)-001 | MD | ยง 812.46
(b) - (c) || EN || ยง 812.46 Monitoring investigations. [โฆ] (b) Unanticipated adverse device effects. (1) A sponsor shall immediately conduct an evaluation of any unanticipated adverse device effect. (2) A sponsor who ... | ||
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.3 (q) | MD | ยง 812.3
(q) || EN || (q) Termination means a discontinuance, by sponsor or by withdrawal of IRB or FDA approval, of an investigation before completion. | ||
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.46 (b) - (c)-002 | MD | ยง 812.46
(b) - (c) || EN || ยง 812.46 Monitoring investigations [โฆ] (b) Unanticipated adverse device effects. [โฆ] (c) Resumption of terminated studies. If the device is a significant risk device, a sponsor may not resume a ... | ||
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.150 (a) (2) | MD | ยง 812.150
(a) (2) || EN || ยง 812.150 Reports. (a) Investigator reports. An investigator shall prepare and submit the following complete, accurate, and timely reports: (2) Withdrawal of IRB approval. An investigator shall ... | ||
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.150 (b) (1) - (3) | MD | ยง 812.150
(b) (1) - (3) || EN || ยง 812.150 Reports. (b) Sponsor reports. [...] (2) Withdrawal of IRB approval. A sponsor shall notify FDA and all reviewing IRB's and participating investigators of any withdrawal of approval of an ... | ||
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.150 (b) (7)-001 | MD | ยง 812.150
(b) (7) || EN || ยง 812.150 Reports. (b) Sponsor reports. [...] (7) Final report. In the case of a significant risk device, the sponsor shall notify FDA within 30 working days of the completion or termination of the ... | ||
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.140 (d) | MD | ยง 812.140
(d) || EN || ยง 812.140 Records. [โฆ] (d) Retention period. An investigator or sponsor shall maintain the records required by this subpart during the investigation and for a period of 2 years after the latter of ... | ||
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.140 (e) | MD | ยง 812.140
(e) || EN || ยง 812.140 Records. [โฆ] (e) Records custody. An investigator or sponsor may withdraw from the responsibility to maintain records for the period required in paragraph (d) of this section and transfer ... | ||
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.36 | MD | ยง 812.36 | EN | ยง 812.36 Treatment use of an investigational device. (a) General. A device that is not approved for marketing may be under clinical investigation for a serious or immediately life-threatening disease ... |
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.150 (a) (3) | MD | ยง 812.150
(a) (3) || EN || ยง 812.150 Reports. (a) Investigator reports. An investigator shall prepare and submit the following complete, accurate, and timely reports: (3) Progress. An investigator shall submit progress reports ... | ||
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.150 (b) (5) | MD | ยง 812.150
(b) (5) || EN || ยง 812.150 Reports. (b) Sponsor reports. [...] (5) Progress reports. At regular intervals, and at least yearly, a sponsor shall submit progress reports to all reviewing IRB's. In the case of a ... | ||
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.150 (a) (6) | MD | ยง 812.150
(a) (6) || EN || ยง 812.150 Reports. (a) Investigator reports. An investigator shall prepare and submit the following complete, accurate, and timely reports: [...] (6) Final report. An investigator shall, within 3 ... | ||
| Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.150 (b) (7)-002 | MD | ยง 812.150
(b) (7) || EN || ยง 812.150 Reports. (b) Sponsor reports. [...] (7) Final report. In the case of a significant risk device, the sponsor shall notify FDA within 30 working days of the completion or termination of the ... |
