FDA-Regulated Devices Used in Research

Flowchart

SOP 023: Research Involving Investigational Devices and HUDs

Frequently Asked Questions (FAQs)

1. What is a medical device?

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
  
• And 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.
  

2. When is a study of a medical device regulated by the FDA?

FDA regulations apply when a study evaluates the safety or effectiveness of a medical device in subjects, healthy control subjects, or human specimens. FDA Informed Consent and IRB (21 CFR 50, 56) regulations apply as well.

3. What is a clinical investigation?

A clinical investigation or research involving one or more subjects to determine the safety or effectiveness of a device (21 CFR 812.3(h)). Not a clinical investigation if the device is only being used to elicit or measure a physiological response or clinical outcome and no data will be collected on or about the device itself

4. My device is FDA approved or cleared. Do I need to do anything else?

It depends. If you are using approved or cleared device for its approved use, then the device is likely IDE exempt. If you are using the approved or cleared device for an unapproved use, please use the flow chart to determine if your study falls under the IDE exempt criteria, is a nonsignificant risk device (subject to an abbreviated IDE), or a significant risk device (full IDE requirements). Please note: The IRB must review and concur with your preliminary evaluation.

5. What is an Investigational Device Exemption (IDE) and when is it necessary?

An IDE is a regulatory submission that permits clinical investigation of devices to determine safety and effectiveness. An approved investigational device exemption (IDE) permits a device that otherwise would be required to comply with a performance standard or to have premarket approval to be shipped lawfully for the purpose of conducting investigations of that device (21 CFR 812.1). An IDE is necessary when a study is determining the safety and effectiveness of a device (unless exempted). 

6. What is meant by IDE exempt?

The FDA has specific criteria for devices to be IDE exempt. Please see the flowchart linked at the top of the page.

1. FDA approved/cleared devices for approved use.
2. Diagnostic device that is non-invasive, does not require invasive procedure, does not introduce energy into a subject, will not be used as a diagnostic without confirmation, results will not be used to make clinical decisions
3. If not determining safety or effectiveness
1. Customer preference
2. Testing of a modification or combination
3. Custom device intended for use by an individual patient

7. Who decides whether a device is non-significant risk (NSR) or significant risk (SR)?

The sponsor or sponsor-investigator is responsible for making the initial NSR-SR determination. The IRB is responsible for reviewing and concurring with or disagreeing with, the sponsor's assessment. If the sponsor has a letter from the FDA indicating that the device is NSR, the IRB must accept that decision (the FDA's determination is final). Otherwise, if the IRB disagrees with the sponsor's determination that the device is NSR, the sponsor must request that the FDA issue its opinion.

8. If the IRB has determined that the device meets the definition of an NSR device, do I need to get an IDE from the FDA?

No. If the IRB concurs with the sponsor's NSR determination, then it is effectively issuing an abbreviated IDE to conduct the study. NSR device studies must follow the abbreviated requirements under 21 CFR 812.2(b) and the FDA's regulations for Human Subjects Protections and the IRB operations (21 CFR 50 and 56).

9. Does FDA require IRB review and approval of off-label use of a legally marketed device?

No, 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. Yes, 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)). For additional information on the off-label use of devices, see the FDA Information Sheet guidance, “ ‘Off-label’ and Investigational Use of Marketed Drugs, Biologics and Medical Devices.”

10. My sponsor initially determined my device is NSR but the IRB determined it was SR. What do I need to do?

The sponsor must obtain one of the following from the FDA: (1) a determination that the device is an NSR device or (2) an IDE (in the event the FDA agrees that the device is an SR device).

11. Can a physician use an unapproved device in an emergency?

In general, an unapproved medical device may be used only on human subjects when the device is under clinical investigation and when used by investigators participating in a clinical trial. Section 561 of the Act, however, recognizes that there may be circumstances under which a health care provider may wish to use an unapproved device to save the life of a patient or to conditions constituting the emergency, patient outcome information, and the patient protection measures that were followed. Please visit our Emergency Use page for more information.

12. What if the situation is not an emergency? Can a patient with a serious illness or condition have access to an investigational device outside a study?

Yes, FDA recognizes that there are circumstances in which an investigational device is the only option available for a patient faced with a serious or life-threatening condition, known as compassionate use, or expanded access. Please visit our Expand Access page for more information.