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Investigational Device Exemption (IDE)
3.1 Determining if an IDE Application is needed | 3.2 Compiling an IDE Application | 3.3 IDE Application approval process | 3.4 IDE post approval | 3.5 IDE Compliance with University of Minnesota Policy 2.1.10 | 3.6 FDA’s IDE Rules and Regulations
An IDE is an investigational device exemption. It is documentation submitted to the FDA to allow for the conduct of a clinical study using a significant risk device that is new or not approved for that use.
3.1 Determining if an IDE Application is needed:
To determine if an IDE is needed for your research or study, ask yourself:
Will human subjects receive a significant risk device?
Will human subjects use an approved device for an unapproved use?
If yes to either question then most likely an IDE Application is needed.
Dr. Harvey Arbit, Director of the IAP, can conduct a more detailed assessment of your research or study to determine if an IDE is necessary.
In order for him to help you determine IND applicabiliity certain information most be provided:
- Information needed by IAP to determine IDE applicability for a New or Marketed Device
3.2 Compiling an IDE
3.2.1 IDE Application Format
The FDA has set forth a specific format an IDE application must follow. The IAP will help in compiling an IDE application if all the necessary documents are provided.
The necessary documents needed to compile an IDE include:
- Cover letter. (Template for cover letter)
- Monitoring procedures: a written out procedure including name, address and qualification of the monitor
CTMS Monitoring Plan
Investigator Self-Monitoring Plan
- FDA Guidance for the Monitoring of Clinical Investigators
- Investigator information: This contains curriculum vitae of investigator, statement of relevant experience, explanation if involved in a terminated investigation, provide financial disclosure information (form FDA 3454 and 3455) and a statement of the investigator’s commitment to conduct the investigation in accordance with the investigational plan and FDA regulations; supervise all testing of the device; and ensure that the requirements for obtaining informed consent are met.
-Additional Documents needed to compile an IDE
3.2.2 Submitting an IDE Application
3.3 IDE APPLICATION APPROVAL PROCESS
The approval process of an IDE varies, depending on if the IDE is a significant risk device, a non-significant risk device or if the study is exempt form the IDE regulations
Significant risk devices: The FDA will respond with an acknowledgement letter which contains the date that the FDA received the application and an IDE number. This means that the IDE has been successfully filled, however, the clinical investigation can not start until 30 days after the IDE has been received, unless earlier notification by the FDA is received, stating that the studies may begin.
Non-significant risk devices: A non-significant risk device study requires only IRB approval prior to initiation of a clinical study. Sponsors of studies involving non-significant risk studies are not required to submit an IDE application to FDA for approval. Submission of non-significant device investigations are made directly to the IRB. The investigator will need to comply with the abbreviated requirements for an IDE. Sponsors are to present an explanation to the IRB where the study will occur, and why the device does not pose significant risk. If the IRB disagrees and determines that the device poses a significant risk, the sponsor must report this finding to FDA within five working days.
1. IDE Exempt Investigation: The FDA may determine that you study is exempt from FDA regulation. However, the study is still subject to IRB regulation.
The IND/IDE Assistance Program aids in the guidance regarding the applicability of these regulations.
3.4 IDE POST APPROVAL
After approval of an IDE, the Sponsor-Investigator is still subject to conditions set by the FDA and the University of Minnesota
The FDA has set forth responsibilities for the sponsor-investigator of clinical trials:
-Labeling: the device must be labeled in accordance with the labeling provision of the IDE regulation and must bear the statement “CAUTION-Investigational Device. Limited by Federal (or United States) law to investigational Use.”
-IRB approval: The Sponsor-Investigator must obtain and maintain Investigational Review Board (IRB) approval throughout the investigation even if it is a non significant risk device study
-Distribution: Investigational devices can only be distributed to qualified investigators.
-Informed Consent: Each subject must be provided with and sign an informed consent form before being enrolled in the study
-Monitoring: All clinical studies must be properly monitored to protect the human subjects and assure compliance with approved protocols under (see “Guideline for the Monitoring of Clinical Investigations’). Clinical monitoring must be conducted by a qualified individual and monitoring must be documented. A written monitoring plan must be in place for all significant risk an non-significant risk device studies.
CTMS Monitoring Plan
Investigator Self-Monitoring Plan
-Prohibition: Commercialization, promotion, and misrepresentation of the investigational device and prolongation of the study are prohibited.
-Records and Reports: Sponsors-Investigators are required to maintain specified records and make reports to investigators, IRBs and FDA. .
-FDA reporting obligations under an IDE:
Meeting deadlines to submit documentation to the FDA under an IDE
3.5 COMPLYING WITH UNIVERISTY POLICY 2.1.10
University Policy 2.1.10: This policy states that all University of Minnesota faculty members who file an IND/IDE with the FDA as a sponsor-investigator must submit all documents relevant to the IND/IDE to the central university documentation unit (IND/IDE Assistance Program).
IDE Documents that should be sent to the IAP
In order to ensure compliance with University Policy 2.1.10 the IAP will conduct period reviews of your research records.
3.6. FDA’s IDE Regulations
Title 21, Code of Federal Regulations (CFR), Part 812
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