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

FDA Informed Consent and IRB (21 CFR 50, 56) regulations apply when a study evaluates the safety or effectiveness of a medical device on subjects, either patients or healthy controls, or on human specimens, including pre-existing deidentified human specimens.  This document is designed to help investigators determine if and what FDA regulations apply to their studies.

FDA regulations would generally not apply to studies:

  • using an FDA approved device to test physiologic principle where no data is collected about the device;
  • using an FDA approved device to address a research question and no data is collected about the device; or
  • using an FDA approved device for clinical purposes (e.g. monitor a side effect, measure treatment progress);

as long as there is no intent to collect safety or effectiveness data or develop the device for marketing.

An example would be use of an MRI to measure a clinical outcome in a study that has nothing to do with the MRI itself.

Note: even when FDA regulations do not apply, the requirement for IRB approval may still apply under 45 CFR 46.

2. Definitions:

Biological Specimens:  A sample, such as human tissue, blood or urine, used for diagnostic, pathological analyses, or other research purpose.

Medical device: the term ‘device’ means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar related article, including any component, part, or accessory, which is:

(1) recognized in the official National formulary, or the United States Pharmacopeia, or any supplement to them,

(2) 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

(3) intended to affect the structure or function of the body of man or other animals.

Additionally, it does not achieve its primary intended purpose through chemical action within or on the body… and is not dependent upon being metabolized for the achievement of its primary intended purposes (Federal Food, Drug, and Cosmetic Act).

For more information, see the applicable decision tree: Is it a Medical Device?

Sponsor means a person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency, academic Institution, private organization, or other organization. The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator. 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 means an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. The term does not include any person other than an individual. The requirements applicable to a sponsor-investigator include both those applicable to an investigator and a sponsor. The PI must indicate in the IRB submission that he/she is aware of his/her regulatory responsibilities in acting as both the investigator and the sponsor for an FDA-regulated investigation. For additional information about sponsor-investigator responsibilities, please see this Summary of FDA Requirements for Investigators who are also considered Sponsors of New Devices.

3. What are the consent requirements for FDA-regulated studies?

Consent requirements differ slightly for FDA-regulated studies. Consent generally cannot be waived for FDA-regulated research except for limited circumstances involving life-threatening situations, military operations, public health emergencies or for emergency research [21 CFR 50.23 & 50.24]. All elements of consent must be present as it is not possible to waive elements of consent for FDA-regulated research. This means that deceptive methodologies are not permitted.

Under certain additional circumstances when an investigational device will be used on only deidentified specimens, consent requirements may be waived. For more information, please see the FDA Guidance on informed consent for in vitro diagnostic device studies using leftover human specimens that are not individually identifiable.

A waiver of documentation (signature) of informed consent is permitted only for research that presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the research context. Note that for greater than minimal risk research, some minimal risk activities may still qualify for this waiver. For example, a minimal risk eligibility screening conducted over the phone may be conducted without collecting a signature, provided that written consent is obtained for the greater than minimal risk activities.

All consent forms for FDA-regulated research must include a statement that the FDA may inspect research records. OSU template language: The FDA, other federal regulatory agencies and the Oregon State University Institutional Review Board (a committee that reviews and approves research studies) may inspect and copy records pertaining to this research.

4. What is an Investigational Device Exemption (IDE)?

An IDE allows the investigational device to be used in a clinical study in order to collect safety and efficacy data required to support a marketing application. The term “exemption” in this case means exempt from the laws prohibiting unapproved products to move in interstate commerce.

5. When is an Investigational Device Exemption (IDE) required?

FDA Investigational Device Exemptions (IDE) (21 CFR 812) regulations may apply for studies designed to:

  • support marketing applications;
  • collected safety and effectiveness information (e.g. for a new intended use of a legally marketed device or for a newly invented device); and
  • sponsor-investigator studies of an unapproved device or new intended use of an unapproved device even if no marketing application is planned.

6. What are the three regulatory categories for device studies described in the IDE regulations (21 CFR 812)?

Research that involves assessing the safety or effectiveness of a medical device must fit in ONE of the following categories:

  1. Studies exempt from the IDE requirements;
  2. Significant risk (SR) device research with a formal IDE submission to the FDA;
  3. Non-significant risk (NSR) device research which with IRB approval is ‘considered’ to have an approved IDE; sometimes referred to as an abbreviated IDE.

For more information about these categories, please see the OSU decisions trees:

7. Who decides whether a device study is SR or NSR?

Sponsors are responsible for making the initial risk determination and presenting it to the IRB. Unless the FDA has already made a risk determination for the study, the IRB must review the sponsor's SR or NSR determination for every investigational medical device study reviewed and modify the determination if the IRB disagrees with the sponsor. If FDA has already made the SR or NSR determination for the study, the agency's determination is final.

If there is not a sponsor, the investigator should provide their own initial risk determination with justification to the IRB, which will make its own determination at a convened IRB meeting or will refer it to the FDA.

The risk determination is based on how the device will be used in the proposed study. The device SR/NSR determination should not be confused with the “minimal risk” determination or “risk-benefit” assessment for the study in general.

8. When is a study involving a medical device eligible for IRB review using the expedited procedure?

For a device study to be eligible for Expedited Review under Expedited Category 1, the device must present no more than minimal risk to the subject, and meet one of the criteria in expedited Category 1b:

Expedited Category 1b- Research on medical devices for which:

(i) an IDE application (21 CFR Part 812) is not required*; or

(ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling**.

* Example: Study presents documentation from FDA indicating that an IDE application is not required or study meets all criteria to be IDE exempt in vitro diagnostic device. Per guidance from the FDA, an NSR determination made at a convened meeting can fit into expedited 1b(i) since an IDE application is not required for submission to the FDA.

** An approved Device used in research according to its approved labeling is considered Exempt from IDE requirements.

Note: Expedited Category 1 should not be used for studies that involve use of a device only, (no testing or data collected on or about the device), as FDA regulations do not apply. Expedited Category 4 (collection of data through noninvasive procedures routinely employed in clinical practice) may be considered for studies that use, but do not test, a device.

9. When is a study of a Mobile Medical Application regulated by the FDA?

Many software applications intended for use on mobile platforms (mobile applications or “mobile apps”) are not considered medical devices. However, some mobile apps may meet the definition of a medical device and depending on the potential risk to the subjects are regulated by the FDA. For more information about when a mobile app is considered a medical device and when FDA-regulations apply, see this FDA Guidance on Mobile Medical Applications.

Adapted from: University of Kentucky, IRB Review of Medical Device Research, 2013.

Additional Sources:

  • Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors, Significant Risk and Nonsignificant Risk Medical Device Studies, January 2006
  • Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors Frequently Asked Questions About Medical Devices, January 2006
  • Code of Federal Regulations, Title 21 CFR 812, Investigational Device Exemptions
  • IDE Definitions and Acronyms