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A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is:
- Recognized in the official United States Pharmacopeia and The National Formulary, or any of its supplements.
- Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.
- Intended to affect the structure or any function of the body of man or other animals.
- Which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals; and which is not dependent upon being metabolized for the achievement of its primary intended purposes (21 U.S.C. 321(h)).
The U.S. Food and Drug Administration (FDA) classifies devices in three main regulatory categories based on the risk:
- Class I devices are subject only to general controls. They typically present the lowest potential for harm and are simpler in design than Class II or Class III devices. Examples of Class I devices include elastic bandages, examination gloves, and hand-held surgical instruments.
- Class II devices are those for which general controls alone are insufficient to provide a reasonable assurance of safety and effectiveness. In addition to complying with general controls, Class II devices are also subject to special controls identified by the agency, which may include special labeling requirements, performance standards and postmarket surveillance. Examples of Class II devices include powered wheelchairs, infusion pumps, and surgical drapes.
- Class III devices generally are those for which insufficient information exists to determine that general or special controls are sufficient to provide a reasonable assurance of safety and effectiveness. Examples of Class III devices include replacement heart valves, silicone-gel-filled breast implants, and implanted cerebellar stimulators.
Types of Device Studies Covered by IDE Regulations (21 CFR Part 812)
The FDA Investigational Device Exemptions (IDE) regulation ( 21 CFR 812) describes three types of device studies: significant risk (SR), nonsignificant risk (NSR), and exempt studies.
Significant Risk (SR) Device Studies
A significant risk device means an investigational device that (21 CFR 812.3(m)):
- 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 use 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.
- Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.
For a comprehensive list of SR device examples please refer to the FDA information sheet “Significant Risk and Nonsignificant Risk Medical Device Studies."
Non-Significant Risk (NSR) Device Studies
An NSR device is an investigational device that does not meet the definition of a significant risk device.
For a comprehensive list of NSR device examples please refer to the FDA information sheet “Significant Risk and Nonsignificant Risk Medical Device Studies.”
In accordance with 21 CFR 812.2(b), sponsors and investigators of certain studies are exempt from the requirements of 21 CFR Part 812, with the exception of §812.119 (disqualification of a clinical investigator). Examples of exempt studies are consumer preference testing, testing of a device modification, or testing of two or more devices in commercial distribution if the testing does not collect safety or effectiveness data, or put subjects at risk.
In addition, diagnostic device studies (e.g., in vitro diagnostic studies) are exempt from the requirements of 21 CFR Part 812 under certain circumstances.
If an exempt device study is being conducted to collect data to support either a clinical investigation or a marketing application, then the study must comply with 21 CFR Part 50 and should comply with 21 CFR Part 56. 21 CFR 50.1(a), 21 CFR 50.20, 21 CFR 56.101(a), 21 CFR 56.103.
When reviewing a device trial, the Institutional Review Board (IRB) will make the following decisions, based on the guidance provided by the FDA in “Significant Risk and Nonsignificant Risk Medical Device Studies”:
- IRBs should make the SR or NSR determination about a study by reviewing relevant information at a convened meeting. This information includes the description of the device, reports of prior investigations conducted with the device, the proposed investigational plan, and subject selection criteria. The sponsor should provide the IRB with a risk assessment and the rationale used in making its SR or NSR determination.
- An IRB may agree or disagree with the sponsor’s initial NSR assessment.
- If the IRB determines the study is NSR, the IRB may approve the study using the criteria at 21 CFR 56.111. The study may begin without submission of an IDE application to FDA.
- If the IRB disagrees with the sponsor’s NSR assessment and decides the study is SR, the IRB must tell the clinical investigator, and where appropriate, the sponsor. (See 21 CFR 812.66).
- An IRB may approve the study as an SR device study, but the study may not begin until FDA approves the sponsor’s IDE application.
- To facilitate the IRB’s review of the study, an IRB may ask the sponsor for proof that an SR study has an FDA-approved IDE application (i.e., a copy of FDA’s approval or conditional approval letter).
- The IRB should document its SR/NSR determination in the IRB meeting minutes.
Special Device Use Cases
- Emergency Use Device
- Compassionate Use Device
- Custom device use: FDA regulations do not require review and approval for custom device use. To be considered a custom device, the device must meet all of the criteria, which are described in section 520(b) of the act and at 21 CFR 812.3(b).
- Humanitarian Use Device Guidance
- Off-label use of a legally marketed device: When a physician uses a legally marketed device outside its labeling to treat a patient and no research is being done, IRB review is not required. Note: Although not required by FDA, an IRB may still decide on its own initiative to review such use. When the off-label use of a legally marketed device is part of a research study collecting safety and effectiveness data involving human subjects, IRB review and approval is required (21 CFR 812.2(a)).
When the investigator is also the sponsor, the investigator assumes the responsibilities of the sponsor in addition to those of the investigator. Additional guidance regarding sponsor responsibilities for SR and NSR devices can be found in Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors, Significant Risk and Nonsignificant Risk Medical Device Studies as well as 21 CFR 812, Subpart C:Responsibilities of Sponsors and 21 CFR 812, Subpart E:Responsibilities of Investigators.
- FDA section 21 CFR 812
- FDA Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors, Frequently Asked Questions About Medical Devices
- FDA Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors, Significant Risk and Nonsignificant Risk Medical Device Studies