Medical DevicesLast reviewed April 2026

Investigational Device Exemption(IDE)

FDA authorization allowing an unapproved medical device to be used in a clinical investigation to collect safety and effectiveness data.

Usage Examples

The SR-IDE was approved after FDA's 30-day review, and the pivotal trial enrolled the first patient the following week.
The device was classified as non-significant risk, so only IRB approval was required to start the study.
IDE data from the 400-patient trial formed the clinical evidence core of the subsequent PMA application.

What is IDE?

An Investigational Device Exemption (IDE) is FDA's regulatory mechanism that permits a medical device not yet cleared or approved for marketing to be used in a clinical study. The IDE exempts the investigational device from certain FDA requirements that would otherwise apply (such as premarket notification or approval) so that clinical data supporting a future 510(k), De Novo, or PMA submission can be gathered.

IDEs are classified by risk: significant risk (SR) studies require full FDA IDE approval before the study can begin, while non-significant risk (NSR) studies only require IRB approval and sponsor record-keeping. FDA has 30 days to review an SR-IDE application before the study may proceed.

IDE studies must comply with 21 CFR Part 812 requirements including investigator agreements, informed consent, IRB oversight, device accountability, and adverse event reporting. Clinical data from an IDE study typically forms the core evidence package for a subsequent PMA or De Novo filing.

Regulatory Context

This term appears most often in medical devices workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside 21 CFR 812, FDCA SECTION 520.

FDA CDRHEMAHealth Canada

When This Matters

The SR-IDE was approved after FDA's 30-day review, and the pivotal trial enrolled the first patient the following week.
The device was classified as non-significant risk, so only IRB approval was required to start the study.
IDE data from the 400-patient trial formed the clinical evidence core of the subsequent PMA application.

Common Mistakes

Using drug-only submission assumptions for device regulatory pathways.
Ignoring post-market obligations in pre-market planning.
Weak predicate and classification rationale in dossier narratives.

Related Regulations

21 CFR 812FDCA SECTION 520

How to Submit an IDE Application to FDA

Submit an Investigational Device Exemption to authorize clinical investigation of an unapproved medical device.

1
Determine risk classification
Assess whether the device is Significant Risk (SR) requiring full IDE approval, or Non-Significant Risk (NSR) requiring only IRB approval. SR classification is driven by device type, indication, and procedure invasiveness.
2
Prepare the IDE application
Compile required content per 21 CFR 812.20: report of prior investigations, investigational plan, manufacturing information, investigator information, IRB information, sponsor information, and labeling. File through CDRH Portal.
3
File IRB submissions in parallel
Each clinical site's IRB must approve the study before enrollment. For NSR studies, IRB approval alone is sufficient; for SR studies, IRB approval plus FDA IDE approval are both required.
4
Wait for FDA 30-day review
FDA has 30 days from receipt to respond. If FDA does not object within the window, the study may proceed. Conditional approvals may require modifications before enrollment.
5
Implement IDE requirements
Execute investigator agreements, informed consent per 21 CFR 50, device accountability records, adverse event reporting, and IDE-specific records per 21 CFR 812.140.
6
File supplements as needed
Protocol amendments, new investigators, and device modifications require IDE supplements. Changes affecting scientific soundness or subject rights require prior FDA approval.

Frequently Asked Questions

Significant Risk (SR) devices present a potential for serious risk to subject health, safety, or welfare and require full FDA IDE approval before the study begins. Non-Significant Risk (NSR) devices have lower risk profiles and only need IRB approval plus sponsor record-keeping.

FDA has 30 days from receipt of an SR-IDE application to respond. If FDA does not disapprove within that window, the sponsor may proceed with the study subject to any conditions.

No. IDE approval only permits clinical investigation; it does not indicate FDA's view of the device's likelihood of eventual clearance or approval. The resulting clinical evidence is evaluated separately during 510(k), De Novo, or PMA review.