Investigational Device Protocols

What information does the IRB need to know before approving your device study?

  • Does the study involve: (1) The use of a medical device in one or more persons that evaluates the safety or effectiveness of that device, or (2) Data regarding the use of a device on human specimens? Indicate if a device is used in the research.
  • Is the investigator seeking a device exemption for the proposed study?
  • Will the study be conducted under an approved IDE (submission to FDA) or can it be conducted under an abbreviated IDE (NSR determination made and reviewed by the IRB)?
    • *See definition section for italicized terms

SmartForm Sub-Section: Devices:

Identify all devices being evaluated for safety or effectiveness or as a comparator (approved and unapproved). For each, indicate whether it has an IDE number and for those that do, ensure that the application includes one of the following: (a) sponsor protocol with the IDE number; (b) communication from the sponsor with the IDE number; or (c) communication from the FDA with the IDE number. Indicate whether the device is being submitted under the “Abbreviated IDE requirements” in 21 CFR 812.2(b). Additionally attach the following items:

  • Current Product Information, e.g., Device Manual. Submit for each investigational device involved in the Human Research.
  • Validation of IND# or IDE#, e.g. FDA Approval letter or Sponsor Protocol

Definitions

Medical Device – An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article or component part or accessory which  is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease;  which affects the structure or any function of the body to achieve its primary intended purposes through physical action and NOT chemical or metabolic action

Investigational Device Study -When the objective of the study is to assess the safety and/or effectiveness of a medical device, then the study is a device study and is subject to regulatory oversight by the US Food and Drug Administration (FDA), unless exempted under 21 CFR 812.

Note: If a device is being used as a tool and the objective of the study is not to test its safety and efficacy, the scope of the study would not be regulated under 21 CFR 812.

Investigational Device Exemption (IDE) – A submission to the FDA that allow the clinical investigation of devices, collection of safety and efficacy data, and shipment of device(s) across state lines.

510(K) – Device commercialization path which requires demonstration that the device is as safe and effective, or substantially equivalent to a legally marketed device (predicate) that is not subject to a Pre-market approval (PMA). FDA has a 90 day review period for these.  Additional guidance on the 510K process can be found here.

PMA – Premarket approval device commercialization path required for class III devices after safety and efficacy studies have been completed. FDA has a 180 day review period prior to granting approval for these.

Medical Device Classifications

Devices are classified by the associated risk. Class I – lowest risk; Class II – moderate risk; Class III – highest risk.

Typically Class I and II are non-significant risk (NSR) devices. Class III are significant risk (SR) devices.

Visit the FDA device database to see a list of medical devices with their associated classification product codes.

A significant risk device (SR) is one that:

  •  Is intended as an implant and presents a potential for serious risk to the health, safety, and welfare of a subject.
  •  Is used to support or sustain human life.
  •  Is of substantial importance in diagnosing, curing, mitigating, or treating disease and/or otherwise preventing impairment of human health.
  •  Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.

Non-Significant Risk (NSR) device studies do not need an IDE application submitted to FDA. NSR devices may include dental flosses, scissors, syringes MRI, wheel chair, etc.

• The IRB serves as the FDA’s surrogate for review, approval, and continuing review of NSR device studies.

• NSR device studies must follow the abbreviated IDE requirements under 21 CFR 812.2 (b):

  1. Label the device properly
  2. Obtain and maintain IRB approval after presenting why the device study is NSR
  3. Obtain informed consent
  4. Monitor the study
  5. Maintain required records and reports
  6. Comply with prohibitions against promotion

Note: The IRB and/or the Sponsor (with appropriate justification to the IRB) can make the SR/NSR determination.  If there is a disagreement between the IRB and Sponsor, the FDA will have the final say.

IDE Exemptions – The following criteria must be met for a study to be exempted from the IDE requirements:

    • A legally marketed device when used in accordance with its labeling.

• A diagnostic device meeting 4 specified criteria:

  1.  Is non invasive (e.g. – penetrate or pierce the skin or mucous  membranes of the body   or any other body openings)
  2.  Does not require an invasive sampling procedure that presents a significant risk (e.g. – biopsy of a major organ, use of general anesthesia, or placement of a blood access line into an artery or large vein)
  3.  Does not by design or intention introduce energy into a subject
  4.  Is not used as a diagnostic procedure without confirmation of the diagnosis by another medically established diagnostic product or procedure

• A device undergoing a consumer preference testing, testing of modification or testing of a combination of two or more devices in commercial distribution if the testing is not for the purpose of determining safety or effectiveness.

• A device intended solely for veterinary use.

• A device for research on or with laboratory animals.

• A custom device. (21 CFR 812.3(b))

In Vitro Diagnostics (IVD)

An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article or component part or accessory that:

  • Is intended for use in the diagnosis of disease or other condition, or in the cure, mitigation, treatment, or prevention of disease, or
  • Is intended to affect the structure or any function of the body
  • And achieves it’s primary intended purposes through physical action and NOT chemical or metabolic action

Note: IVD products are intended for use in the collection, preparation, and examination of specimens taken from the human body (e.g – Blood, spinal fluid, tissue samples, serum, urine) and are different from other medical devices as they do not function on or in a subject. For additional frequently asked questions regarding IVD products, click here.

IDE Preparation and Maintenance (for Sponsor-Investigators)

IDE Format and Content (3 copies required to be submitted to FDA):

  • Form 3514 (cover sheet)
  • Name and Address of Sponsor
  • Reports of Prior Investigations (e.g. prior clinical, animal or lab studies)
  • Investigational Plan
  • Manufacturing Information
  • Investigator’s Agreement
  • Investigator’s Certification
  • IRB Information
  • Name and Address of Investigator’s Institutions
  • Financial Claims
  • Environmental Assessment
  • Labeling
  • Informed Consent
  • Additional Information

Note:  A Letter of Authorization from the manufacturer (states that confidential information from their IDE can be used in support of investigator’s IDE submission) can be used to reference italicized sections above.  

Where to submit initial IDE submission (for Sponsor-Investigators)?:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center – WO66-G609 10903 New Hampshire Avenue Silver Spring, Maryland 20993-0002

Note: FDA will respond within 30 days via an ‘Acknowledgement letter‘ with the IDE Number. The name of your FDA Project Manager will also be listed on the letter.

Sponsor-Investigators are notified of the date the FDA receives the eCopy.  If the eCopy is missing you will be placed on eCopy hold.   If issues cannot be resolved within the 30 day period the IDE will be approved with conditions or disapproved. Click here to learn more about the FDA review process.

IDE Maintenance for Sponsor-Investigators:
Sponsor-Investigators are required to notify the FDA and the IRB of changes to their protocol/Investigational plan. The FDA should be notified of changes via one of 3 ways: IDE Supplements, IDE Reports, or IDE Amendments. The information within these notifications to the FDA may include:

  • Changes that require prior FDA approval. These fall under the 30-day reply window from the FDA (e.g. changes may impact data validity, participant safety or welfare)
  • Changes that DO NOT require prior FDA approval can be submitted via a 5-day notice (e.g. minor/non-significant changes that don’t impact scientific soundness or impact participants rights, welfare, or safety)
  • Changes submitted as a part of the annual report (e.g. summary from the previous year related to device monitoring, labeling, Informed Consent, etc.)
  • Unanticipated Adverse Device Effects (UADE) – serious and/or life-threating events not previously identified should be reported as soon as Investigator is aware with a follow-up report within 10 working days
  • Progress and annual reports may include study progress information related to enrollment, device shipment, adverse events, deviations, new risks associated with the device, and future plans.

Click here to learn more about when and how to submit the notification(s) to the FDA.

Additional Types of IDE studies

  • Expanded Access – Emergency use of an investigational device may be granted for individuals who may be facing a serious, life-threatening situations and/or for whom there is no alternative treatment.  These protocols are often referred to as Single Patient/Compassionate Use studies – For more guidance on the FDA’s policy on early and expanded use click here.  Please note, notifying IRB review is also required.
  • Treatment IDE – For serious and/or life-threatening conditions for which no alternative therapy exist. IRB approval is required.
  • Continued Access – There is a public health need for the device. The investigational trials have been completed and marketing application has been submitted to FDA. Initial study data shows the device is likely to be effective and there are no safety concerns.
  • Humanitarian Use – Intended to treat or diagnose disease/condition that affects fewer than 4,000 individuals. Humanitarian Device Exemption does not require effectiveness requirement to be met.  IRB approval is still required prior to use of device. 

Terminating/Closing IDE 
A Sponsor-Investigator may withdraw an IDE for any reason.  Both the FDA and IRB should be notified if this becomes the case. In addition, the FDA may inactivate an IDE if there is no communication (annual report updates/amendments) for 2 years.  If no IDE correspondence is submitted for greater than 5 years, the FDA can terminate the IDE.

  • Note: The FDA can also terminate an IDE if there are any safety concerns.  The Sponsor-Investigator will have an opportunity to respond if this termination notification if this is the case.

Requirements for New IDE Holders

  • Following IRB approval, Sponsor-Investigators are required to contact the Quality Improvement Program to discuss their research protocol and ensure they are meeting their FDA Sponsor-Investigator Responsibilities.  Prior to the first continuing review and every 2 years thereafter, until the protocol closes, Sponsor-Investigators are encouraged to contact QIP to conduct an onsite review of their protocol.

Tools/Checklist: