May 8, 2024
At Folio Consulting Group, LLC we work with a lot of innovative, higher risk medical devices that require clinical data for the PMA, De Novo or 510(k) submissions. In order to conduct a clinical study in the US for a high risk medical device, an exemption from the FDA is required to use your device in humans without first having an FDA clearance or approval in place.
The exemption that allows you to use your medical device in human subjects in the US is called an Investigational Device Exemption (IDE), 21 CFR Part 812, which you can obtain from the FDA. An IDE allows you to use your investigational device in a clinical study to collect safety and effectiveness data to be used in a future premarket submission [PMA, De Novo or 510(k)].
Per 21 CFR 812.1 “An approved IDE permits a device that otherwise would be required to comply with a performance standard or to have premarket approval to be shipped lawfully for the purpose of conducting investigations of that device.” In this blog post, we'll guide you through the process of obtaining an IDE.
Step 1: Determine if You Need an IDE
First, determine whether your study requires an IDE. The IDE regulation describes three different types of studies: significant risk (SR), nonsignificant risk (NSR), and exempt studies. Sponsors are responsible for determining the initial risk determination and getting alignment with their investigational site Institutional Review Board (IRB). FDA is also available through the Pre-Submission process for help in determining the risk of the clinical study.
You'll need an IDE if your study involves a significant risk device, which is an investigational device that:
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 use 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.
If your device does not meet these criteria, it may be considered a non-significant risk device, and you may not need an IDE. However, you should still consult with an institutional review board (IRB) for study review and approval.
IRB approval is also required for significant risk clinical studies; however, this typically takes place after FDA approves your IDE.
Step 2: Prepare Your IDE Application
If your study requires an IDE, you'll need to prepare an IDE application and submit it to FDA for review and approval. The application should include:
A complete investigational plan, including the purpose of the study, the protocol, a risk analysis, a description of the device, and a description of the methods, facilities, and controls used for the manufacture, processing, packaging, and storage of the device 21 CFR 812.20(b)(3);
A description of the methods, facilities, and controls used for the manufacture, processing, packaging, storage, and installation of the device 21 CFR 812.20(b)(3);
An investigator agreement 21 CFR 812.43(c);
A list of the names, addresses, and chairpersons of each Institutional Review Board (IRB) that has or will be asked to review the investigation 21 CFR 812.20(b)(5);
A certification that all participating investigators have signed the agreement 21 CFR 812.20(b)(6);
A list of the name, address, and qualifications of each investigator 21 CFR 812.20(b)(7);
A description of the controls that will be used to ensure that the device will be used only by authorized investigators 21 CFR 812.20(b)(8);
Copies of all labeling for the device 21 CFR 812.20(b)(10); and
Information regarding previous investigations and marketing history 21 CFR 812.20(b)(2).
The FDA has detailed information on the IDE application process and the content of an IDE. Keep in mind, as long as your device design does not change, most of the non-clinical testing used to support the IDE can also be used in the future 510(k) or De Novo Classification Request.
Step 3: Submit Your IDE Application
Once you've prepared your IDE application, you can submit it to the FDA through the Center for Devices and Radiological Health (CDRH) Document Control Center. IDE applications do not have FDA review fees. The FDA will review your application within 30 days and notify you if your IDE is approved, approved with conditions, or disapproved.
If approved with conditions or disapproved, FDA will provide details in their review letter of the information, testing or documentation still needed.
Step 4: Conduct Your Clinical Study
If your IDE is approved, you can begin conducting your clinical study. While designing your clinical study, ensure Good Clinical Practices (GCPs) are followed. GCPs refers to the regulations and requirements that must be complied with while conducting a clinical study. These regulations apply to the manufacturers, sponsors, clinical investigators, institutional review boards, and the medical device. The primary regulations that govern the conduct of clinical studies are included in the Code of Federal Regulations, Title 21 (21 CFR):
21 CFR 812, Investigational Device Exemptions, covers the procedures for the conduct of clinical studies with medical devices including application, responsibilities of sponsors and investigators, labeling, records, and reports.
21 CFR 50, Protection of Human Subjects, provides the requirements and general elements of informed consent;
21 CFR 56, Institutional Review Boards, covers the procedures and responsibilities for institutional review boards (IRBs) that approve clinical investigations protocols;
21 CFR 54, Financial Disclosure by Clinical Investigators, covers the disclosure of financial compensation to clinical investigators which is part of FDA’s assessment of the reliability of the clinical data.
21 CFR 820 Subpart C, Design Controls of the Quality System Regulation, provides the requirement for procedures to control the design of the device in order to ensure that the specified design requirements are met.
You must also report any unanticipated adverse device effects, withdrawal of IRB approval, and other required information to the FDA and all reviewing IRBs 21 CFR 812.150.
Step 5: Inform FDA of Any Changes to Your Investigational Device or Study
Once you have the IDE approval in place, you are required to report any changes to FDA following FDA Guidance, Changes to Modifications During the Conduct of a Clinical Investigation.
FDA approval, through an IDE Supplement, is required for changes to the investigational device, including manufacturing changes, that constitute a significant change in design or basic principles of operation, or are not made in response to information gathered during the course of an investigation. Changes to the investigational device that do not represent a significant change and are made in response to information from the investigation can be reported to FDA in a 5-Day Notice.
FDA approval through an IDE Supplement is also required for changes to the clinical study protocol that impact the validity of data/information, patient risk to benefit relationship, scientific soundness of the plan, or rights, safety or welfare of subjects. Changes to the clinical protocol that do not impact these items can be reported to FDA in a 5-Day Notice.
Minor investigational plan changes that do affect validity of data/information, patient risk to benefit relationship, scientific soundness of plan, or rights, safety or welfare of subjects require FDA approval through an IDE Supplement. Minor investigational plan changes that do not affect validity of data/information, patient risk to benefit relationship, scientific soundness of plan, or rights, safety or welfare of subjects can be reported to FDA in an IDE progress report.
Obtaining an IDE can be a complex process, but by following these steps and complying with the FDA's regulations, you can successfully and compliantly conduct a clinical study for your medical device. If you have any questions or need assistance, consider consulting with a regulatory expert, like Folio Consulting Group, or the FDA's Division of Industry and Consumer Education (DICE).
Schedule a free, 30-minute initial consultation with our experts at Folio Consulting Group, LLC to see how we can provide your team with regulatory assistance and help prepare your IDE Application.
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