Document:USA 21 CFR Part 812 09-Apr-2025: Difference between revisions
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Latest revision as of 14:15, 16 July 2026
| 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 —Food and Drugs
Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter H—Medical 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
| Scope | Document part | Language | Preview | |
|---|---|---|---|---|
| USA 21 CFR Part 812 09-Apr-2025 Subpart B | MD | Subpart B | EN | Subpart B—Application and Administrative Action
§ 812.20 Application. (a) Submission. […] (b) Contents […]… |
| USA 21 CFR Part 812 09-Apr-2025 Subpart D | MD | Subpart D | EN | Subpart D—IRB Review and Approval
§ 812.60 IRB composition, duties, and functions. An IRB reviewing and approving investigations under this part shall… |
| USA 21 CFR Part 812 09-Apr-2025 Subpart E | MD | Subpart E | EN | Subpart E—Responsibilities of Investigators
§ 812.100 General responsibilities of investigators. An investigator is responsible for ensuring that an i… |
| USA 21 CFR Part 812 09-Apr-2025 Subpart G | MD | Subpart G | EN | Subpart G—Records and Reports
§ 812.140 Records. (a) Investigator records. A participating investigator shall maintain the following accurate, complet… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.1 | MD | § 812.1 | EN | § 812.1 Scope. (a) […] This part provides procedures for the conduct of clinical investigations of devices. An approved investigational device exempti… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.100 | MD | § 812.100 | EN | § 812.100 General responsibilities of investigators. An investigator is responsible for ensuring that an investigation is conducted according to the s… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.110 (b) | MD | § 812.110 (b) | EN | § 812.110 Specific responsibilities of investigators. (b) Compliance. An investigator shall conduct an investigation in accordance with the signed agr… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.110 (c) | MD | § 812.110 (c) | EN | § 812.110 Specific responsibilities of investigators. (c) Supervising device use. An investigator shall permit an investigational device to be used on… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.119 | MD | § 812.119 | EN | § 812.119 Disqualification of a clinical investigator. […]… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.140 (a) (2) | MD | § 812.140 (a) (2) | EN | § 812.140 Records.
[…] (a) Investigator records. A participating investigator shall maintain the following accurate, complete, and current records rel… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.140 (a) (3) | MD | § 812.140 (a) (3) | EN | § 812.140 Records.
[…] (a) Investigator records. A participating investigator shall maintain the following accurate, complete, and current records rel… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.140 (a) (3) (ii) | MD | § 812.140 (a) (3) (ii) | EN | § 812.140 Records. (a) Investigator records. A participating investigator shall maintain the following accurate, complete, and current records relati… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.140 (b) (5) | MD | § 812.140 (b) (5) | EN | § 812.140 Records.
[…] (b) Sponsor records.[...] (5) Records concerning adverse device effects (whether anticipated or unanticipated) and complaints [… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.140 (d) | MD | § 812.140 (d) | EN | § 812.140 Records.
[…] (d) Retention period. An investigator or sponsor shall maintain the records required by this subpart during the investigation a… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.140 (e) | MD | § 812.140 (e) | EN | § 812.140 Records.
[…] (e) Records custody. An investigator or sponsor may withdraw from the responsibility to maintain records for the period require… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.145 | MD | § 812.145 | EN | § 812.145 Inspections (a) Entry and inspection. A sponsor or an investigator who has authority to grant access shall permit authorized FDA employees, … |
| USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (1) | MD | § 812.150 (a) (1) | EN | § 812.150 Reports.
(a) Investigator reports. An investigator shall prepare and submit the following complete, accurate, and timely reports: (1) Unant… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (2) | MD | § 812.150 (a) (2) | EN | § 812.150 Reports.
(a) Investigator reports. An investigator shall prepare and submit the following complete, accurate, and timely reports: (2) Withd… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (3) | MD | § 812.150 (a) (3) | EN | § 812.150 Reports.
(a) Investigator reports. An investigator shall prepare and submit the following complete, accurate, and timely reports: (3) Progr… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (4) | MD | § 812.150 (a) (4) | EN | § 812.150 Reports.
(a) Investigator reports. An investigator shall prepare and submit the following complete, accurate, and timely reports: (4) Devia… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (5) | MD | § 812.150 (a) (5) | EN | § 812.150 Reports.
(a) Investigator reports. An investigator shall prepare and submit the following complete, accurate, and timely reports: (5) Infor… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (6) | MD | § 812.150 (a) (6) | EN | § 812.150 Reports.
(a) Investigator reports. An investigator shall prepare and submit the following complete, accurate, and timely reports: [...] (6) … |
| USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (1) | MD | § 812.150 (b) (1) | EN | § 812.150 Reports.
(b) Sponsor reports. [...] (1) Unanticipated adverse device effects. A sponsor who conducts an evaluation of an unanticipated adver… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (1) - (3) | MD | § 812.150 (b) (1) - (3) | EN | § 812.150 Reports.
(b) Sponsor reports. [...] (2) Withdrawal of IRB approval. A sponsor shall notify FDA and all reviewing IRB's and participating inv… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (5) | MD | § 812.150 (b) (5) | EN | § 812.150 Reports.
(b) Sponsor reports. [...] (5) Progress reports. At regular intervals, and at least yearly, a sponsor shall submit progress reports… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (7)-001 | MD | § 812.150 (b) (7) | EN | § 812.150 Reports.
(b) Sponsor reports. [...] (7) Final report. In the case of a significant risk device, the sponsor shall notify FDA within 30 worki… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (7)-002 | MD | § 812.150 (b) (7) | EN | § 812.150 Reports.
(b) Sponsor reports. [...] (7) Final report. In the case of a significant risk device, the sponsor shall notify FDA within 30 worki… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (8) | MD | § 812.150 (b) (8) | EN | § 812.150 Reports.
(b) Sponsor reports [...] (8) Informed consent. A sponsor shall submit to FDA a copy of any report by an investigator under paragra… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.25 | MD | § 812.25 | EN | § 812.25 Investigational plan.
The investigational plan shall include, in the following order: (a) Purpose. The name and intended use of the device an… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.27 | MD | § 812.27 | EN | § 812.27 Report of prior investigations. (a) General. The report of prior investigations shall include reports of all prior clinical, animal, and labo… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.3 (e) | MD | § 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… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.3 (f) | MD | § 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 in… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.3 (g) | MD | § 812.3 (g) | EN | (g) Investigational device means a device, including a transitional device, that is the object of an investigation.… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.3 (i) | MD | § 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 adminis… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.3 (j) | MD | § 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 investig… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.3 (m) | MD | § 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 healt… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.3 (n) | MD | § 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, d… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.3 (o) | MD | § 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 im… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.3 (p) | MD | § 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… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.3 (q) | MD | § 812.3 (q) | EN | (q) Termination means a discontinuance, by sponsor or by withdrawal of IRB or FDA approval, of an investigation before completion.… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.3 (r) | MD | § 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 d… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.3 (s) | MD | § 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 ass… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.3 (t) | MD | § 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 we… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.30 | MD | § 812.30 | EN | § 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 ma… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.30 (b) - (c) | MD | § 812.30 (b) - (c) | EN | § 812.30 FDA action on applications
[...] (b) Grounds for disapproval or withdrawal. FDA may disapprove or withdraw approval of an application if FDA … |
| USA 21 CFR Part 812 09-Apr-2025 § 812.35 | MD | § 812.35 | EN | § 812.35 Supplemental applications
(a) Changes in investigational plan — (1) Changes requiring prior approval […] (2) Changes effected for emergency u… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.36 | MD | § 812.36 | EN | § 812.36 Treatment use of an investigational device. (a) General. A device that is not approved for marketing may be under clinical investigation for … |
| USA 21 CFR Part 812 09-Apr-2025 § 812.40 | MD | § 812.40 | EN | § 812.40 General responsibilities of sponsors. Sponsors are responsible for selecting qualified investigators and providing them with the information … |
| USA 21 CFR Part 812 09-Apr-2025 § 812.42 | MD | § 812.42 | EN | § 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 appl… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.43 | MD | § 812.43 | EN | § 812.43 Selecting investigators and monitors.
(a) Selecting investigators. […] (b) Control of device […] (c) Obtaining agreements [...] curriculum vi… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.43 (c) (5) | MD | § 812.43 (c) (5) | EN | § 812.43 Selecting investigators and monitors. (c) Obtaining agreements. A sponsor shall obtain from each participating investigator a signed agreemen… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.43 (c) (4) | MD | § 812.43 (c) (4) | EN | § 812.43 Selecting investigators and monitors.
[…] (4) A statement of the investigator's commitment to: (i) Conduct the investigation in accordance wi… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.45 | MD | § 812.45 | EN | § 812.45 Informing investigators. A sponsor shall supply all investigators participating in the investigation with copies of the investigational plan … |
| USA 21 CFR Part 812 09-Apr-2025 § 812.46 (a) | MD | § 812.46 (a) | EN | § 812.46 Monitoring investigations (a) Securing compliance. A sponsor who discovers that an investigator is not complying with the signed agreement, t… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.46 (b) | MD | § 812.46 (b) | EN | § 812.46 Monitoring investigations
[…] (b) Unanticipated adverse device effects. (1) A sponsor shall immediately conduct an evaluation of any unantici… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.46 (b) - (c)-001 | MD | § 812.46 (b) - (c) | EN | § 812.46 Monitoring investigations.
[…] (b) Unanticipated adverse device effects. (1) A sponsor shall immediately conduct an evaluation of any unantic… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.46 (b) - (c)-002 | MD | § 812.46 (b) - (c) | EN | § 812.46 Monitoring investigations
[…] (b) Unanticipated adverse device effects. […] (c) Resumption of terminated studies. If the device is a signific… |
| USA 21 CFR Part 812 09-Apr-2025 § 812.7 (c) | MD | § 812.7 (c) | EN | § 812.7 Prohibition of promotion and other practices. A sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator shal… |
