Investigational Device Exemption (IDE)
What
What is an IDE?
An Investigational Device Exemption (IDE) is a regulatory submission that permits an investigational device to be used in a clinical study in order to collect safety and effectiveness data.
What is a Device?
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article or component part or accessory which:
- is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease
- is intended to affect the structure or any function of the body
- does not achieve any of 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
Non-traditional medical devices
- In Vitro Diagnostics (IVDs): reagents, instruments, and systems intended for use in diagnosis of disease or other conditions.
For example, pregnancy test, HIV blood screening test, oncogene testing
- Mobile Medical Applications: a mobile app that incorporates device software functionality that meets the definition of device in section 201(h) of the FD&C Act
- Software Functions: a software function that is intended to perform a medical device function (to diagnose disease or other conditions, or cure, mitigate, treat, or prevent disease).
See FDA Guidance for Device Software Functions and Mobile Medical Application
What are the Types of IDE?
FDA Oversight IDE per 21 CFR 812.2(a) for Significance Risk (SR) Device
IRB Oversight Abbreviated IDE per 21 CFR 812.2(b)1 for Non-Significance Risk (SR) Device
What are the Classification of Investigational Medical Device?
Significant Risk (SR): require FDA (full IDE application) and IRB approval
- 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 a use in 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.
Non-Significant Risk (NSR): require IRB approval and must meet abbreviated IDE requirement (no prior FDA approval is required)
A non-significant risk (NSR) device is one that does not meet the definition of a significant risk device.
* Initial determination maybe made by sponsor or investigator but ultimate decision in determining SR vs NSR is the FDA’s
See FDA Guidance for SR and NSR
Why
Why do I need an IDE?
An IDE is required by FDA Regulation Title 21 of the Code of Federal Regulations (CFR), Part 812 (21 CFR 812)
Failure to comply may result in termination of IDE, Warning Letters (posted on FDA website), Disqualifications/ Restrictions/ Debarments (posted on FDA website), Criminal prosecutions, prison, and/or fines.
Which
Do I Need an IDE?
Does your research involve:
1. An investigational device?
2. Is the device used in a clinical research investigation with human subjects?
3. Did you/your collaborators (non-industry) design the study?
4. Is it intended to diagnose, cure, mitigate, treat, or prevent disease in a human?
5. Is it intended to affect the structure or any function of the body?
If you answer yes to all questions above, you probably need an investigator-sponsored IDE.
When is a Device Study Exempt from IDE?
Does your research involve:
- A legally marketed device when used in accordance with its labeling.
- A diagnostic device if it complies with the labeling requirements in §809.10(c) and if the testing (see below for more details):
- is noninvasive;
- 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 by another medically established diagnostic product or procedure;
- A device undergoing consumer preference testing, testing of a modification, or testing of a combination of two or more devices in commercial distribution, if the testing is not for the purpose of determining safety or effectiveness and does not put subjects at risk.
- A device intended solely for veterinary use.
- A device shipped solely for research on or with laboratory animals and labeled in accordance with 21 CFR 812.5(c) .
- A custom device, as defined in 21 CFR 812.3(b) , unless the device is being used to determine safety or effectiveness for commercial distribution.
In general, if you answer yes to any questions above, your device investigation maybe exempted from IDE regulation.
When
When Do I Start an IDE Application?
See eIRB, IND/IDE, CT.gov clinical trial reporting timeline
Who
Who needs to submit the IDE?
The Sponsor needs to submit the IDE. This will be the Sponsor-investigator physician for an investigator initiated study.
Who is the Sponsor?
An individual, company, academic institution or other organization that takes responsibility for and initiates a clinical investigation
Who is the Investigator?
An individual who conducts a clinical trial, i.e. under whose immediate direction a drug is administered or dispensed
Who is the Sponsor-Investigator?
An individual who both initiates and conducts an investigation
How
List of regulatory components for initial IDE applications as outlined by FDA
Initial IDE Submission Process
1. Determine whether IDE is required (Schedule a one-on-one consultation!)
2. Prepare IDE Application (see below templates)
3. Material Review (SI Support staff review applications)
4. Submit IDE Application to FDA
IDE Templates, Guidance and Useful Links
IDE Submissions
IDE Initial Application Template
IDE Certification of Financial Interest of Clinical Investigators
IDE Initial Application Cover Letter
IDE Amendments
IDE Transfer of Obligations Template Current SI
IDE Transfer of Obligations Template New SI
IDE Transfer of Obligations Cover Letter
IDE Annual and Final Reports
IDE Annual Report Cover Letter
IDE Safety Reports
IDE Safety/other Report Guidance
IDE Safety/other Report Cover Letter
Useful Links
FDA Guidance: Investigator-Initiated IDE Submissions
FDA Quick Links and Resources: Investigator-Initiated IDE Submissions
21 CFR 812: Code of Federal Regulations - Investigational Device Exemptions
Need assistance or have regulatory questions? Please sisupport@utsouthwestern.edu