Investigational Devices

Features

During a consultation, ORS can help you:

• Understand device classifications
• Determine if an IDE is needed
• Provide guidance for pre-IDE discussions with FDA
• Assist with submission of an IDE to FDA
• Assist with IDE reporting

Get Started

To get started, request an IDE consultation with the ORS.

Navigating FDA-regulated device processes involves a series of decisions, including assessment of the potential risk posed by the device during the course of the study and in its final use. Research studies performed under IDE regulation are subject to differing levels of regulatory control depending on the level of risk. The regulations and approval procedures differ for ‘significant risk’ and ‘non-significant risk’ device studies and some studies are even exempt from IDE regulations.

Device Classifications

The FDA has established classifications and 16 specialty panels for current medical devices. 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 and differing requirements apply to each class.

In-vitro diagnostics (IVDs) are reagents, instruments, and systems intended to diagnose diseases or 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 IVDs may be exempt from IDE requirements if all of the following conditions are met:

• The sponsor has labeled the device 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.
• The testing is not used as a diagnostic procedure without confirmation of the diagnosis by another, medically-established diagnostic product or procedure.

Determination of Need

ORS will help you determine if you need to submit an IDE to the FDA and can help prepare an abbreviated IDE to the IRB, if necessary.

An IDE [21 CFR 812] is filed with the Center for Devices and Radiological Health 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.

Pre-IDE Discussion Guidance

If an IDE is necessary, the FDA encourages new regulatory sponsors to obtain further device guidance prior to submitting an IDE application. Preparing a pre-submission application (previously called a pre-IDE), increases the regulatory sponsor’s understanding of FDA requirements, regulations, and guidance documents.

ORS can help researchers set up a pre-IDE meeting with the FDA and can help prepare the pre-IDE package and participate in associated communications.

IDE Submission

ORS can help investigators assemble their IDE submission and can provide guidance on meeting both paper and eCopy submission requirements.The IDE application format required by the FDA can be found at the Center for Devices and Radiological Health IDE policies and procedures website. The required documents include a cover letter, monitoring procedures, investigator information, and information about the device.

Filing Annual Reports and Amendments to the FDA

The study may begin 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. Reports must be submitted to the FDA on an annual basis, at minimum, as well as when changes take place in the format or structure of the study. Unanticipated adverse device effect reporting is also critical to the continued operation of any clinical trial and must be submitted to the IRB and FDA within 10 days of the event.

ORS will remind researchers about reporting milestones, help prepare reports, and assist researchers in abiding by the proper reporting procedures.

Get Training

ORS offers 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. 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.

• University of Rochester faculty and staff Access to IND training through MyPath (search for "Investigational Device Exemption").
• Rochester students may request access by contacting the Office of Regulatory Support.
• Those not affiliated with the University of Rochester can access the IDE training after filling out a brief survey.

If you are interested in learning a bit more about what happens during an FDA audit and how you can be prepared for one, watch this short Preparing for an FDA Audit training video.

Resources

ORS can provide templates for many of the FDA submissions during the lifetime of an IDE. Contact Research Help if you need assistance with drafting communications to the FDA or for templates for any of the following items:

• Cover letter
• Pre-submission meeting request and briefing package
• IDE application
• IDE progress report
• Final reports

Contact

Joan E. Adamo, Ph.D., Director of  Regulatory Support
Joan_Adamo@urmc.rochester.edu, (585) 275-0742

Reshma Ravilla, Pharm.D., Regulatory Affairs and Compliance Specialist
Reshma_Ravilla@urmc.rochester.edu

Carrie Dykes, Ph.D., Research Engagement Specialist
Carrie_Dykes@urmc.rochester.edu,  (585) 275-0736

Shelby Johnson, Administrative Support
Shelby_Johnson2@urmc.rochester.edu, (585) 275-5327