FDA IDE and Medical Device Clinical Studies: Significant Risk, ISO 14155 and Sponsor Duties
When a device study needs an IDE, how significant risk and non-significant risk studies differ, what sponsors, investigators and IRBs must do, and how ISO 14155 fits.
When a new device needs clinical data, the study has to follow rules that protect participants and make the data credible. In the US that means the Investigational Device Exemption (IDE) regulations; internationally, ISO 14155 sets good clinical practice for device studies. This guide explains when an IDE is needed, how significant risk and non-significant risk studies differ, and what sponsors and investigators must do.
What an IDE is
An IDE allows an investigational device to be used in a clinical study to collect safety and effectiveness data, even though the device is not yet cleared or approved. The rules are in 21 CFR Part 812. Studies that need FDA approval of an IDE application are those of significant risk (SR) devices. Studies of non-significant risk (NSR) devices follow abbreviated requirements and do not need an IDE application to FDA.
Significant risk or non-significant risk?
A device study is significant risk if the device:
- is an implant that presents a potential for serious risk to health, safety or welfare;
- is used in supporting or sustaining human life and presents such a risk;
- is of substantial importance in diagnosing, curing, mitigating or treating disease, or preventing impairment of health, and presents such a risk; or
- otherwise presents a potential for serious risk to health, safety or welfare of a subject.
The sponsor makes the first determination, and the reviewing IRB can disagree. If the IRB considers the study significant risk, an IDE application to FDA is needed. When unsure, many sponsors ask FDA through a Pre-Submission.
Who does what
| Role | Main responsibilities |
|---|---|
| Sponsor | Study design, monitoring, selecting qualified investigators, IDE application where needed, supplying and tracking the device, safety reporting, records and reports to FDA and investigators |
| Investigator | Following the protocol, obtaining informed consent, controlling the device, recording data, reporting adverse events, keeping records |
| IRB | Reviewing and approving the study and consent materials, ongoing review, risk determination for the study |
Core requirements
- Informed consent under 21 CFR Part 50 and IRB review under Part 56.
- Investigational labelling: the device must carry the statement that it is limited by federal law to investigational use.
- No promotion: an investigational device must not be promoted as safe or effective for the purpose under investigation.
- Charging: sponsors can charge for an investigational device only to recover costs, and FDA expects the basis to be documented.
- Financial disclosure by clinical investigators for studies that support marketing applications (21 CFR Part 54).
- Registration and results: certain device clinical trials must be registered on ClinicalTrials.gov. Check whether your study is an applicable clinical trial.
- Records and reports: progress reports, unanticipated adverse device effect reports, final report and record retention.
FDA has 30 days to review a new IDE application and may approve it, approve it with conditions or disapprove it. Many sponsors reduce risk by discussing the study design with FDA beforehand.
ISO 14155 and good clinical practice
ISO 14155 is the international standard for good clinical practice in clinical investigations of medical devices in human subjects. It covers planning, conduct, recording and reporting, and addresses ethics, risk management, monitoring, safety reporting and quality. FDA’s rules are not identical to ISO 14155, but aligning your study with both is common when data will serve more than one market. The EU MDR also expects clinical investigations to follow the relevant standards and legal requirements. For the EU side, see clinical evaluation under EU MDR.
Planning a device study: a short checklist
- Decide the question the study must answer and what evidence regulators and payers will need.
- Confirm the risk determination (SR or NSR) and whether to hold a Pre-Submission meeting.
- Prepare the protocol, investigator brochure, risk analysis and biocompatibility and bench evidence.
- Control the device under design controls and manufacture it under your quality system.
- Set up monitoring, data management, adverse event handling and a safety review process.
- Plan how study data will feed the submission and later post-market follow-up.
Common mistakes
- Starting a study before the risk determination and IRB review are settled.
- Changing the device mid-study without assessing the effect on data.
- Weak source documentation and inconsistent records across sites.
- Endpoints that do not match what the marketing submission needs.
Frequently asked questions
Do all device studies need an IDE?
No. Non-significant risk studies follow abbreviated requirements, and some studies are exempt. A significant risk study needs an approved IDE.
Is an IDE the same as a 510(k)?
No. An IDE lets you study a device clinically. A 510(k), De Novo or PMA is a marketing submission. Study data often supports one of those later.
Does ISO 14155 replace FDA rules?
No. It is a recognised good clinical practice standard, but US studies must still follow 21 CFR Parts 50, 54, 56 and 812.
Who can serve as an investigator?
A qualified person responsible for conducting the study at a site, usually a clinician with the relevant training and facilities. The sponsor must select investigators qualified by training and experience.
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