Devices

This guidance is intended to assist investigators in meeting the FDA requirements when investigating medical devices in clinical research and in some treatment situations. Federal regulation 21 CFR 812 defines the requirements for clinical investigations of medical devices.

In This Section

What is the Requirement?

Investigators or sponsors must obtain an Investigational Device Exemption (IDE) from the FDA before beginning a clinical investigation of a significant risk device. In addition, an IRB must approve investigations of medical devices in humans.

When is an IDE from the FDA required?

  • Studies involving unapproved devices that are considered to be significant risk

    • An IDE from the FDA is required to perform clinical research using an unapproved device that poses a significant risk to subjects. Typically, these studies are conducted to collect safety and effectiveness data used to support Premarket Approval (PMA) applications submitted to the FDA.
    • Example: Significant risk (SR) studies involve implantable devices such as cardiac pacemakers, orthopedic implants, and stents. SR studies can also involve products not introduced into the body, such as computer software used for prenatal risk evaluation. Each of these studies would require an IDE. For more information, see FDA guidance on Significant and Non-Significant Risk Medical Devices.

  • Studies involving an approved device being tested for a new indication

    • IDE regulations also apply to significant risk studies testing an FDA-approved device for a new indication.
    • Example: A legally marketed coronary stent would be considered an investigational device and would require an IDE if used as part of a study to collect safety and effectiveness data for treating occlusions of other vascular sites.

When is an IDE from the FDA not required?

  • Studies involving devices that are considered to be Non-Significant risk (NSR)

    • An IDE from the FDA is not needed for research when the sponsor provides a brief explanation of why the device is NSR and the IRB agrees with the sponsor’s explanation.
    • The following guidance includes examples of significant-risk devices and NSR devices: Significant and Non-Significant Risk Medical Devices.

Process for obtaining an IDE

  • Pre-IDE Process: Investigators considering submitting an IDE application to the FDA should communicate with the reviewing division of the Office of Device Evaluation (ODE) prior to the submission of an IDE application. See the FDA IDE Approval Process website for details.
  • The IDE Submission: The IDE submission to the FDA and the IRB application should be initiated at the same time. The FDA has 30 days to review the IDE application. Likewise, the IRB typically reviews an application within a 30-day window, but it may take longer to secure approval. Subjects may not be recruited or enrolled before FDA and IRB approval.

How Do I Comply With the Requirement?

Initial Review Application

On the ”Medical Device(s)” page you will find the following information and question: 

 The risks of all medical devices specified by the protocol must be described in the consent document. This includes risks of approved devices and investigational devices. 

 A device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is: 

  • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, 
  • 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, or 
  • intended to affect the structure or any function of the body of man or other animals, and 

 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 any of its primary intended purposes. 

 From FDA How to Determine if Your Product is a Medical Device 

 Question

 Are any medical devices being studied in this project?

Mark “Yes” only if this research involves a device that is not FDA-approved, is not approved for use as described in this research, or is operating under an IDE; this is an investigational device. 

On the ”Medical Device(s) Information” page you will be asked for more details about the investigational device. 

Device Name

IDE Exemptions

A device may be exempt from the requirement for an Investigational Device Exemption (IDE) if it belongs to one of the following categories: 

  • A device in commercial distribution before May 28, 1976 
  • A device that FDA has determined to be substantially equivalent to a device in commercial distribution before May 28, 1976 
  • A diagnostic device, if testing is non-invasive, does not require an invasive sampling procedure that presents significant risk, does not by design or intention introduce energy into a subject, and is not used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure. 
  •  This device is not FDA-approved or not approved for use as described in this research. 
  • This device is exempt from the requirement for an IDE. 

Significant Risk Device

A significant risk device is a 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 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; or 
  • Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.

Examples include sutures, cardiac pacemakers, hydrocephalus shunts, and orthopedic implants. 

Non-Significant Risk Device

Non-Significant Risk devices are devices that do not pose a significant risk to the human subjects. Examples include most daily-wear contact lenses and lens solutions, ultrasonic dental scalers, and Foley catheters.

From FDA IDE Approval Process

Device risk category

Which category do you believe this device falls into? 

  • Significant Risk Device 
  • Non-Significant Risk Device 
  • N/A – This device is exempt from the requirement for an IDE 

Justification for Non-Significant Risk Determination

If applicable, please provide justification for the Non-Significant Risk determination. 

Do you have an IDE/HDE for use of this device in this study? 

If yes, what is the IDE/HDE Number? 

(If the device is approved and will either be used according to its approved labelling or is believed to be a NSR device, please provide the PMA or 510K number in answer to this question and provide evidence of the PMA or 510K in your application. Example: PMA #: ######## or 510K #: #######) 

Do you believe this device is exempt from the requirement for an IDE?

Ethical Considerations

For investigations involving a medical device that is exempt from the requirement for an IDE, the IRB may approve the study without an IDE.

For research that is not exempt from the requirement for an IDE, the IRB will determine if the investigational device is a significant risk device based on the information in the application.

  • If the IRB agrees that the device is NSR, an IDE from the FDA will not be required.
  • If the IRB determines that the device poses a significant risk, then the study will be reviewed at the Full Committee level for future submissions.

Investigator Responsibilities for Investigational Devices

Control of Investigational Devices

Investigators conducting studies in which an investigational device will be used must ensure adequate control of the device. Adequate control and handling of investigational devices include all of the following:

  • Ensuring that the investigational device is used only as described in the IRB approved protocol, the signed agreement, the investigational plan and applicable FDA regulations.
  • Providing the investigational device only to participants under the investigator’s direct supervision or under the supervision of a sub-investigator responsible to the investigator.
  • Supplying the investigational device only to persons authorized to receive the device.
  • Maintaining accurate, complete, and current records relating to the investigator’s participation in an investigation, including records of receipt, use or disposition of a device that relate to:
    • The type and quantity of the device, dates of its receipt, and the batch number or code mark.
    • The names of all persons who received, used, or disposed of each device.
    • Why and how many units of the device have been returned to the sponsor, repaired, or otherwise disposed of.
  • Returning any unused devices or following the sponsor’s requirements for disposition of unused devices if the investigation is terminated, suspended, discontinued, or completed. See Sample Investigational Device Accountability Log.

Importing Medical Devices

A complete overview of medical device import/export regulations is provided by the Center for Devices and Radiological Health (CDRH). Clinical investigators should be aware that the FDA does not recognize regulatory approvals from other countries. Therefore, an imported medical device must meet all FDA requirements.

  • The IDE sponsor must be located in the United States.
  • Anyone who intends to import an investigational device takes on the responsibilities of a sponsor.

Investigator Reporting Requirements

Unanticipated Adverse Device Effect (UADE)

Unanticipated adverse device effect (any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.)

  • Report to IRB within 5 days of knowledge
  • Report to sponsor within 10 days of knowledge

Protocol Deviation to Protect Life or Physical Well-Being of a Subject

  • Report to sponsor and IRB within 5 working days of deviation

Use of an Investigational Device without Informed Consent

  • Report to sponsor and IRB within 5 working days after use

Withdrawal of IRB Approval

  • Report to sponsor within 5 days of knowledge

Progress Report

  • Report to sponsor, monitor, and IRB no less than annually

Final Report

  • Report to sponsor and IRB within 3 months after termination or completion of study

Humanitarian Device Exemptions (HDE)

An HDE is a type of Pre-Market Approval (PMA) that allows the FDA to grant an exemption from the effectiveness requirements of the PMA regulations. Devices approved with an HDE are referred to as a Humanitarian Use Devices (HUD). The provisions for obtaining an HDE are:

  • The device is designed to treat or diagnose a disease or condition that affects fewer than 8,000 individuals per year in the U.S.
  • The device is not available otherwise, and there is no comparable device available to treat or diagnose the disease or condition; and
  • The device will not expose patients to unreasonable or significant risk, and the benefits to health from the use outweigh the risks.

Treatment under an HDE is not considered research, but the FDA requires IRB approval prior to use. The IRB looks at the safety of the device and decides what information patients should receive about the safety and effectiveness of the HUD. Physicians who want to use a HUD at UC Davis should submit a standard IRB application and indicate on the electronic Initial Review Application that the device is a HUD.

Drug-Device Combination Products

If an investigator is interested in investigating a combination product, the following links may be useful:

  • The FDA’s Office of Combination Products (OCP) was created in 2002 to facilitate the review process for combination products by coordinating interactions between reviewing branches.
  • The OCP provides applicable guidance documents for combination products.
  • Some recent combination product approvals include:
    • Drug-eluting coronary stents;
    • Spinal fusion putty; and
    • An influenza vaccine administered via an intranasal delivery device.

Device Classifications

The level of regulatory controls placed on a medical device is determined by the risk classification. Most research reviewed by the IRB involves significant risk, Class III devices. To help determine device classification, regulatory controls, and exemptions, the CDRH maintains:

  • A searchable classification database containing information about all approved Class I, Class II, and Class III devices.
  • A listing of Class I and Class II devices deemed exempt from Premarket Notification 510(k) regulations.

Definitions

Investigational Device

Investigational device means a device, including a transitional device, that is the object of an investigation. A medical device is considered investigational if either condition applies:

  • The device is not approved for marketing in the United States or
  • The device is approved for marketing but is being clinically evaluated for a new indication.

Investigational Device Exemption (IDE)

IDE refers to the regulations under 21 CFR 812. An approved IDE means that the IRB (and FDA for significant risk devices) has approved the sponsor’s study application and all the requirements under 21 CFR 812 are met.

Significant Risk Device

A 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 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;
  3. 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
  4. Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.

Non-Significant Risk (NSR) Device

A Non-Significant Risk (NSR) device study is one that does not meet the definition for a Significant Risk device study.

IDE Exempt

IDE Exempt means a study that is exempt from the requirements of regulations under 21 CFR 812. Two common investigations of medical devices that are exempt from the requirement for an IDE include:

  • Investigations conducted with legally marketed devices used according to labeling.
  • Studies using in vitro diagnostic devices labeled “for research purposes only” may be IDE-Exempt as per regulations if the testing:
    • Is non-invasive;
    • Does not require invasive sampling procedures that presents significant risk;
    • Does not introduce energy into a subject; and
    • Is not used as a diagnostic procedure without confirmation by another medically established diagnostic product or procedure

Resources

FDA References

FDA Regulations

  • Investigational Device Exemptions: 21 CFR 812
  • Premarket Approval of Medical Devices (includes HUDs): 21 CFR 814
  • Medical Device Classification Procedures: 21 CFR 860
  • Requirements for Device Registration and Listing: 21 CFR 807
  • Electronic Records; Electronic Signatures: 21 CFR 11
  • Financial Disclosure by Clinical Investigators: 21 CFR 54
  • Quality System Regulation: 21 CFR 820