An investigational device exemption (IDE) allows an investigational device to be used in a clinical study to collect data on its safety and effectiveness.^[1] This exemption applies to the conduct of trials necessary for developing new medical devices. Clinical studies are often conducted to support a Premarket Approval (PMA) application, though some 510(k) submissions may require clinical data.

In this blog post, we discuss key considerations for assessing the need for an IDE and complying with the reporting requirements under the IDE program.

Requirement for an IDE

To determine whether an IDE applies to a device study, consider the following:

Indication. If a new, existing, or significantly modified device is being used in a clinical study to determine its safety and effectiveness for a new indication, an IDE is likely required.

Risk category. If the study is considered a significant risk device study, an IDE is required. Significant risk is generally associated with devices that meet any of the following criteria: ^[2]

• Is invasive or intended as an implant that presents a potential risk to the health, safety or welfare of a subject
• Is used for supporting or sustaining human life and presents a potential for serious risk to the health, safety or welfare of a subject
• Is used as the sole basis for—or of substantial importance in—diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of health, and presents a potential for serious risk to the health, safety or welfare of a subject
• Otherwise presents a potential for serious risk to the health, safety or welfare of a subject

The FDA has published an Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors: Significant Risk and Nonsignificant Risk Medical Device Studies to help determine whether a device study poses a significant risk.²

Existence of a predicate device. If there is no comparator device, an IDE is likely required.

Under section §812.10, a sponsor may request a waiver of any requirement of the IDE regulations through an application with supporting documentation. The FDA may grant a waiver if the requirement is not stipulated by the Federal Food, Drug, and Cosmetic (FD&C Act) or if it is not necessary for the protection of human subjects.^[3]

Reporting responsibilities under an IDE

For clinical studies conducted under an IDE, both the sponsor and the investigators must comply with certain reporting and recordkeeping requirements.

Sponsor responsibilities

Sponsors are responsible for reporting on unanticipated adverse device effects, notifying on withdrawal of IRB or FDA approval, submitting copies of investigator reports on failure to obtain informed consent, and providing progress reports to all reviewing institutional review boards (IRBs) at regular intervals or at least yearly. View the suggested format for the progress report here. The sponsor is also responsible for notifying IRBs and the FDA of any request that an investigator return, repair, or dispose of any unit of the investigational device.^[4]

For a significant-risk device, the sponsor must:²

• Submit a progress report to the US Food and Drug Administration (FDA) on a yearly basis
• Submit a current list of the names and addresses of all investigators participating in investigation of that device to the FDA every six months. In some cases, the FDA may grant a waiver allowing the sponsor to submit this investigator list as part of the annual progress report, instead of every six months.
• Notify the FDA and all reviewing IRBs of the completion or termination of the investigation within 30 working days
• Submit a final report to the FDA and all reviewing IRBs within 6 months after the completion or termination of the investigation. . View the suggested format for the final report here.

Investigator responsibilities

Under section §812.150 of the IDE regulations, an investigator must provide the following to the sponsor in a timely manner:^[2]

• Reports of any unanticipated adverse device effects as soon as possible but no later than 10 working days after the investigator learns of the effect. These reports also need to be submitted to the reviewing IRB.
• Notification of IRB withdrawal, within 5 working days.
• Progress reports at regular intervals but no less than yearly. These progress reports must also be submitted to the monitor and the reviewing IRB.
• Notification of any deviation from the investigational plan to protect a subject in an emergency. This notice should be provided as soon as possible but no later than 5 working days after occurrence of the emergency and should also be sent to the reviewing IRB. If the deviation from the investigational plan is not an emergency, the investigator must seek prior approval from the sponsor. If the deviation may affect the scientific soundness of the investigational plan or the rights, safety, or welfare of study subjects, the sponsor is required to obtain prior IRB approval. The sponsor must also obtain FDA approval for a significant risk device investigation by submitting an IDE supplement.²
• Reports of any failure to obtain informed consent.
• A final report within 3 months after termination or completion of the investigation. This report also needs to be submitted to the reviewing IRB.

Key takeaway

The IDE program allows device developers to test their products in clinical studies, enabling the collection of data that supports the clinical utility of the product. Engaging with the FDA through the IDE process provides opportunities for early feedback and guidance from the agency. These interactions can be invaluable in refining study protocols and ensuring compliance with regulatory requirements.

In addition to supporting regulatory submissions, evidence of clinical utility can aid market adoption post-approval and study results can be used in marketing and educational materials to inform potential users of the benefits of the device. Clinical data obtained under an IDE may also be useful for discussions with payers for reimbursement.

Contact us to learn more about obtaining an IDE or conducting a clinical study under an IDE.

Resources

[1] US Food and Drug Administration. Investigational Device Exemption. Available at https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/investigational-device-exemption-ide.

[2] US Food and Drug Administration. Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors: Significant Risk and Nonsignificant Risk Medical Device Studies, January 2006. Available at https://www.fda.gov/media/75459/download.

[3] US Food and Drug Administration. FAQs about Investigational Device Exemption. Available at https://www.fda.gov/medical-devices/investigational-device-exemption-ide/faqs-about-investigational-device-exemption.

[4] US Food and Drug Administration. IDE Reports. Available at https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-reports.