An overview of 21 CFR Part 812

By
Wendy Levine
-
June 21, 2023
An overview of 21 CFR Part 812

This document is a summary of the regulation and does include wording taken directly from the regulation itself. The original regulation should be referenced directly, however, for complete information when submitting an IDE request.

What is an investigational device exemption?

An investigational device exemption (IDE) allows a device to be used in a clinical study prior to obtaining market approval to collect safety and effectiveness data. Clinical studies are typically required to support a Premarket Authorization (PMA), but a small percentage of 510(k) applications also require clinical data when a predicate device comparison is inappropriate for the submission.  

Before a clinical study is initiated, an investigational device must have an approved IDE, unless it is exempt. Devices may be exempt from IDE requirements if they are noninvasive diagnostic devices, being used for consumer preference testing unrelated to device safety or efficacy, or intended solely for veterinary use or research with laboratory animals. Refer to the full text of 21 CFR 812 for details and additional exemptions.

Part 812 – General Provisions (Subpart A)

Scope

This regulation is applicable to all clinical investigations of devices used to determine safety and effectiveness, except where exempt.

Applicability

Abbreviated Requirements

Investigations are considered automatically approved for IDEs if the device is not considered a significant risk, unless the FDA has specifically notified the sponsor otherwise. In these cases, the sponsor must still obtain IRB approval for the investigation and must comply with other requirements of Part 812, including proper labeling, record keeping, and conformed consent requirements.

Exempted investigations

IDEs are not required for devices that fall into one of the following categories:

  • Devices that were in commercial distribution prior to May 28, 1976 that were used or investigated according to requirements in effect at that time. Devices that were introduced after May 28, 1976 but which have been found to be substantially equivalent to devices introduced earlier may also be exempt. This exemption is limited for Class II and III devices from the date an FDA regulation or order calls for the submission of a PMA (in the case of an unapproved Class III device) or establishes a performance standard for a Class II device.
  • Diagnostic devices for which the testing is noninvasive and without significant risk, and is not used as a diagnostic procedure without confirmation through another product or procedure.
  • Devices undergoing consumer preference testing, or testing of a device modification or combination of already distributed devices, if the testing is not for purposes of determining safety or efficacy and does not put subjects at risk.
  • Devices solely for veterinary use.
  • Devices intended for research on or with laboratory animals.
  • A custom device that is not being used to determine safety or efficacy for commercial distribution.

Definitions

21 CFR Part 812.3 provides definitions for many terms, some of which are listed here.

Institution: 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 adjunct to providing residential or custodial care to humans. For example, a hospital, retirement home, confinement facility, academic establishment, and device manufacturer. The term has the same meaning as “facility.”

Institutional Review Board (IRB): Any board, committee, or other group formally designated by an institution to review biomedical research involving subjects and established, operated, and functioning in conformance with part 56. The term has the same meaning as “institutional review committee.”

Investigational device: A device, including a transitional device, that is the object of an investigation.

Investigator. 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 subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team.  

Monitor: When used as a noun, this term 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 sponsor or a consultant to the sponsor, or an employee of or consultant to a contract research organization. Monitor, when used as a verb, means to oversee an investigation.  

Significant risk device means an investigational device that:  

  • Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;  
  • Is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject;  
  • Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or  
  • Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.  

Sponsor: 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 of another individual. A person other than an individual that uses one or more of its own employees to conduct an investigation that it has initiated is a sponsor, not a sponsor-investigator, and the employees are investigators.  

Sponsor-investigator: An individual who both initiates and actually conducts, alone or with others, an investigation, that is, under whose immediate direction the investigational device is administered, dispensed, or used. The term does not include any person other than an individual. The obligations of a sponsor-investigator under this part include those of an investigator and those of a sponsor.  

Subject: 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.  

Labeling of investigational devices

An investigational device or its packaging requires a label with the following information:

  • Name and place of business of the manufacturer, packer, or distributor (per 801.1).
  • Quantity of contents.
  • Statement: “CAUTION—Investigational device. Limited by Federal (or United States) law to investigational use.”
  • Any additional relevant contraindications, hazards, adverse effects, interfering substances or devices, warnings, and precautions.
  • If used for animal research, a statement of “CAUTION—Device for investigational use in laboratory animals or other tests that do not involve human subjects” must be on the label.

IDE Labeling cannot have any statement that is false or misleading and cannot represent the device as safe nor effective.  

Prohibition of promotion and other practices

An investigational device is intended for use only within an investigation. Therefore, until a device is approved for commercial distribution by the FDA, the sponsor or investigator (or those working on their behalf) cannot:

To continue reading this Regulatory Brief, please download the full document here.

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