Investigational New Devices

A medical device is considered investigational if (1.) the device is not approved for marketing in the U.S. or (2.) the device is approved for marketing but is being clinically evaluated for a new indication.

The Food and Drug Administration (FDA) regulates research involving medical devices, as well as all aspects of device manufacturing, marketing and distribution (Code of Federal Regulations Title 21, parts 800-1299). The FDA website contains several sets of useful and readable guidance documents about investigational devices, including mobile devices.

There are two types of clinical studies involving medical devices that require than an Investigational Device Exemption (IDE) be obtained from the FDA in addition to IRB approval before a research study may commence.

• A clinical study involving an unapproved device that poses significant risk to subjects
  • The majority of IDE studies are conducted to collect safety and effectiveness data used to support Premarket Approval (PMA) applications submitted to the FDA.
  • A clinical study involving an approved (legally marketed) device being tested for a new indication

This includes both new devices as well as FDA approved devices being used or tested in a new way that significantly increases the risks associated with the device.

You will need to have a determination of significant risk or non-significant risk (or exemption) from the sponsor supplying the investigational medical device for study.  If you are the inventor – you become the sponsor and must take on all of the sponsors responsibilities as well as the investigator responsibilities.

Significant Risk     Nonsignificant Risk    Exempt

• FDA guide on Determining Significant Risk and Nonsignificant Risk Medical Device Studies.
• FDA guide to the IDE process – including definitions,  risk determination and investigator requirements.
• FDA FAQ about Medical Devices
• FDA IDE Responsibilities (sponsor, researcher, etc.)

Once you have a determination, you may apply to the IRB.

• Clinical trials and device studies that are conducted through a commercial sponsor will be reviewed by an commercial external IRB.  Your sponsorship budget should account for direct charges from the IRB.
•  Clinical studies conducted on federal grants or University funded may be reviewed by the GS IRB or referred to commercial external review at the discretion of the IRB administration.   Decisions will be based upon the ability of the board to adequately evaluate the risks associated with the study using available expertise.  The cost of external review is the responsibility of the project PI and should be anticipated in planning of the study.

• The investigator will provide the IRB with the significant risk level determination from either the sponsor or if available, the FDA.  (21 CFR 812.2(b)(1)(ii)).   (If the investigator is also the inventor, the investigator becomes the sponsor and must take on all of the sponsors responsibilities as well as the investigator responsibilities.)
• The IRB will review that determination with the supporting documentation.
  • The IRB may also use information from the application, protocol, the investigator’s brochure, package insert, FDA Information Sheets, reports of prior investigations conducted with the device, description of subject selection criteria, monitoring procedures, proposed use of the device, potential harms and other evaluations presented by the sponsor to categorize the device as “SR” or “NSR” or other criteria at its discretion.
• If the IRB disagrees with a sponsor’s classification of a device as NSR,” the investigator must file an IDE application with the FDA to obtain a determination. The IRB will abide by the FDA’s determination.
  • If an IDE application is or has been submitted to FDA, but final approval has not been granted, the IRB can proceed with the review of the study, but final approval will not be granted until documentation of the FDA approval is submitted.
  • Once the IDE is obtained, the investigator may submit the IDE# and FDA letter to the IRB for The study will be reviewed by the IRB at the next convened meeting.
• The investigation cannot proceed until the FDA IDE application approval is complete or NSR determination affirmed and the IRB has approved the study under the regulations for the protection of human subjects.
• Once approved, the investigator is responsible for following FDA requirements for recordkeeping and reporting.
• Amendments or corrections of deficiencies required by FDA during the IDE process must be submitted for review and approval of the IRB.
• Reporting:
  • The IRB will record its determination of SR/NSR status in the minutes of the The minutes will describe the IRB’s reasons for its SR or NSR determination and may also include the documents used to establish the IDE status for the study. For an SR determination, such documentation may include a copy of the IDE approval or conditional approval letter from FDA. For an NSR determination, the documentation may include FDA’s NSR classification if the agency has made such a determination.
  • The IRB will review reports of unanticipated device effects. Investigators are required to report these events to the IRB within 10 working days of their receipt of the information.  Should the IRB determine that the information gained in these reports changes the risk assessment; the IRB can reconsider any NSR decision at any time during the study and/or require the modification of the informed consent to contain the new information.