Index: Investigational Devices

Investigational Device Classification

Overview of IDE Requirements &
Applicable Regulations

Guidance

Significant Risk (SR) Devices

A significant risk device means and 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 the 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.

(21 CFR 812.3(m))

• IDE needed
• IDE issued by FDA only
• Follow all IDE regulations

IDE Regulations:
21 CFR 812

Consent and IRB Review:
21 CFR 50 & 56

Significant Risk and Nonsignificant Risk Medical Device Studies (FDA Information Sheet; Includes examples of SR and NSR devices)

Frequently Asked Questions About Medical Devices (FDA Information Sheet)

Off-Label and Investigational Use of Marketed Drugs, Biologics, and Medical Devices (FDA Information Sheet)

FAQ about IDE (FDA Guidance)

Drug-Device Combination Products (FDA Guidance)

Mobile Medical Applications (Apps) (FDA Guidance)

Preparation Packet for Investigator-Initiated Drug and Device Studies (UU Guidance)

Non Significant Risk (NSR) Devices 

A non significant risk device is one that does not meet the definition for a significant risk device. 

(FDA Information Sheet Guidance: Significant Risk and Nonsignificant Risk Medical Device Studies. January 2006)

• IDE needed
• IDE issued by FDA or IRB
• Follow abbreviated IDE regulations

Abbreviated IDE Regulations:
21 CFR 812.2(b)

These abbreviated requirements address labeling, IRB approval, informed consent, monitoring, records, reports, and prohibition against promotion. However, there is no need to make progress reports or final reports to FDA. 

Pre-NSR Device Audit Checklist [DOC] 
(NOTE: A pre-NSR audit is not usually required.  The IRB will notify you during pre-review if an audit is needed.)

Consent and IRB Review:
21 CFR 50 & 56

Exempt Devices 

Exemption categories are defined in 21 CFR 812.2(c).

• No IDE needed
• Exemption issued by IRB
• Follow regulations consent and IRB review 

Consent and IRB Review:
21 CFR 50 & 56

In-Vitro Diagnostic (IVD) Device Studies FAQ (FDA Guidance)

Informed Consent for In-Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable (FDA Guidance)

Humanitarian Use Devices (HUD)

As defined in 21 CFR 814.3(n), a HUD is a “medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year.” 

A Humanitarian Device Exemption (HDE) is an application that is similar to a premarket approval (PMA) application, but is exempt from the effectiveness requirements of sections 514 and 515 of the Food, Drug, and Cosmetic Act (the Act). FDA approval of an HDE authorizes an applicant to market a Humanitarian Use Device (HUD), subject to certain profit and use restrictions set forth in section 520(m) of the Act. Specifically, as described below, HUDs cannot be sold for profit, except in narrow circumstances, and they can only be used in a facility after an IRB has approved their use in that facility, except in certain emergencies. 

(Humanitarian Device Exemption (HDE) Regulation: Questions and Answers. March 18, 2014)

Treatment use of an HUD under an HDE is not considered investigational. 

Expanded Access to Investigational Devices

The Food and Drug Administration's Expanded Access Program allows for devices that are investigational (i.e., not FDA approved) to be used for treatment use outside of a clinical trial.