The Investigational Devices Exemption (IDE) application, which is submitted to the FDA and allows for the conduct of a clinical study using a significant risk device that is either new or has not yet been approved for that requested use.
A Devices and IDE Training Module, designed as an introduction to the field of Medical Devices, to provide training in the process of filing an IDE as the Regulatory Sponsor and to educate on FDA requirements, is offered through Blackboard. This training lasts approximately one and a half hours and is required for any investigator who will be submitting an IDE to the FDA, and optional (but strongly recommended) for study coordinators and research staff involved with the submission and maintenance of an IDE.
Navigation of FDA-regulated device processes involves a series of decisions, including assessment of the potential risk posed by the device. Research studies performed under IDE regulation are subject to differing levels of regulatory control – depending on the level of risk. The regulations differ between ‘significant risk’ and ‘non-significant risk’ device studies. Approval procedures for these differ accordingly and some studies are even exempt from IDE regulations.
- Classification of medical devices
- Determination if an IDE is needed
- Guidance for pre-IDE discussions with FDA
- Assistance with submission of an IDE to FDA
- Assistance with fulfilling IDE reporting requirements
- Special considerations for In-Vitro Diagnostics
The FDA has established classifications and 16 specialty panels for current medical devices [21 CFR 862-892]. Every device is assigned to one of three regulatory classes, based on the level of control necessary to assure the safety and effectiveness of the device. The classes are Class I, Class II and Class III and differing requirements apply to each class.
An IDE [21 CFR 812] is filed with the Center for Devices and Radiological Health (CDRH) to use a medical device for investigational purposes in a clinical study when the objective is to collect safety and effectiveness data for a future marketing submission to the FDA. If the device is determined to be a ‘significant risk device,’ then a submission to the FDA will likely be needed. If it is determined to be a ‘non-significant risk device,’ then an abbreviated IDE submitted to the IRB might be all that is required. The IRB would then function as the overseer of the device trial.
The Office of Regulatory Support (ORS) will assist the researcher in determining if an IDE submission to the FDA is required. ORS can also assist with preparations of an abbreviated IDE to the IRB, if necessary.
If it is determined that an IDE is necessary, the FDA encourages new Regulatory Sponsors to obtain further device guidance prior to the submission of an IDE application. Submission of a pre-IDE increases the Regulatory Sponsor’s understanding of FDA requirements, regulations and guidance documents. ORS can assist researchers with setting up a pre-IDE meeting with the FDA, with the content of the pre-IDE package for submission and as a participant in associated communications.
The format that the FDA requires for the IDE application can be found at the CDRH IDE policies and procedures website. The required documents include a cover letter, monitoring procedures, investigator information and information about the device. Support for the investigator during the application process will be to assist in the assembly of the submission and guidance on meeting both paper and eCopy submitting requirements.
After the 30-day period for the FDA to request more information has elapsed, or once the IRB has determined that the non-significant risk device trial may proceed, the study may begin. Regulations require that reports be submitted to the FDA on an annual basis, at a minimum, but also if key changes take place in the format or structure of the study. ORS will assist with both reminding researchers about reporting milestones and also in preparation of reports.
Unanticipated adverse device effect (UADE) reporting is also critical to the continued operation of any clinical trial, and ORS will assist researchers in abiding by the proper reporting procedures. Reports of UADE must be submitted to the IRB and FDA within 10 days of the event.
In-vitro diagnostics (IVDs) are reagents, instruments and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease. Such products are intended for use in the collection, preparation and examination of specimens taken from the human body. IVDs are devices, but may also be classified as biological products in some circumstances. Generally, IVDs are submitted to the FDA through the CDRH [21 CFR § 809.3].
Some in-vitro diagnostics may be exempt from IDE requirements if all of the following conditions are met:
- the sponsor has labeled the devide properly
- the testing is non-invasive
- the testing does not require an invasive sampling procedure that presents significant risk
- the testing does not, by design or intention, introduce energy into a participant; and
- the testing is not used as a diagnostic procedure without confirmation of the diagnosis by another, medically-established diagnostic product or procedure.