Medical devices are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals.
A DEVICE may be a:
- component, part, accessory;
- assay, reagent, or in-vitro diagnostic device;
- software, digital health, or mobile medical app;
- other instrument if intended to affect the structure or function of the body, diagnose, cure, mitigate, treat or prevent disease; or
- a homemade device developed by an investigator or other non-commercial entity and not approved for marketing by FDA.
Does this protocol involve testing (collecting safety or efficacy data) of a medical device including an FDA approved device, unapproved use of an approved device, humanitarian use device, and/or an investigational device?
Yes/No
[Note: If a marketed device(s) is only being used to elicit or measure a physiologic response or clinical outcome, AND, NO data will be collected on or about the device itself, you may answer “no” above, save and exit this section, (Examples: a chemo drug study uses an MRI to measure
tumor growth but does NOT assess how effective the MRI is at making the measurement; an exercise study uses a heart monitor to measure athletic performance but no safety or efficacy information will be collected about the device itself, nor will the data collected be used for
comparative purposes against any other similar device).]
If you answered yes above, please complete the following questions.
Using the "Add Study Device" tool below, list each device tested in this study - Fields are enabled/disabled based on your responses.
+Add Study Device
Device Name: Enter device name
Manufacturer(s): Enter manufacturer(s)
Route of Administration: Enter route of administration
Device(s) Approval Status: FDA Approved-Cleared for Marketing / FDA Approved Humanitarian Use Device (HUD) / FDA Approved but testing unapproved use / Not FDA Approved-Cleared / Unsure
Describe how dispensing of the investigational device will be controlled including policies and procedures for, control, dispensing, and accountability: Enter description
Indicate where the device will be stored and how access to the device will be limited to prevent unauthorized access (e.g., secure, locked storage; signage designating device as HUD or investigational): Enter information
Indicate if specific qualifications or training are required for study personnel to use or administer the device(s). Enter information
If the Principal Investigator (PI) or sub-investigator does NOT have training or experience related to the proposed study with the device(s), indicate plans to obtain or augment applicable qualifications or expertise. Enter information
For “applicable clinical trials” initiated after March 7, 2012, FDA regulations require the informed consent document to include a specific statement informing subjects about trial registration and availability of trial data on clinicaltrials.gov.
If study is registered on clinicaltrials.gov, do all informed consent documents associated with the study include the specific statement? Yes/No/NA (e.g., not an "applicable clinical trial")
Is the study being conducted under a valid Investigational Device Exemption (IDE), Humanitarian Device Exemption (HDE) or Treatment IDE for Compassionate Use? Yes/No
If yes, complete the following:
IDE or HDE #(s): Enter IDE or HDE number(s)
IDE/HDE Submitted/Held by:
- Sponsor Held by: Enter information
- Investigator Held by: Enter information
- Other Held by: Enter information
Check if this is a Treatment IDE or Compassionate Use under the Food and Drug Administration (FDA) Expanded Access program.
For Individual or Small Group Expanded Access, see FDA's Early Expanded Access Program Information, and attach the following:
- FDA expanded access approval or sponsor’s authorization;
- An independent assessment from an uninvolved physician, if available;
- Confirmation of agreement from manufacturer or entity authorized to provide access to the product.
For guidance and reporting requirements at the conclusion of treatment see the Medical Device SOP.
Applicability of Investigational Device Exemption (IDE) Regulatory Requirements.
Exempt Category
- Study is exclusively collection of clinical outcomes (i.e., real world data) on an approved/cleared device used in clinical care. In order to meet this exemption, study must not affect treatment decisions or how the device is administered. Treatment must be based on medical
practitioner's clinical judgment, (e.g., case-control study, clinical outcomes registry). This exemption would not apply if gathering data would influence treatment decisions.
- Testing Clinical Decision Support Software (CDSS) that does NOT meet FDA’s definition of a medical device – For guidance on which algorithms do or do not meet the definition, see FDA Guidance for Clinical Decision Support Software for algorithms developed with artificial
intelligence or machine learning.
- Testing distinct categories of software or digital health products which are excluded from FDA regulations based on the 21st Century Cures Act. Use the FDA Digital Health Policy Navigator to find out if the FDA regulates the app or software. This interactive tool asks simple
questions and indicates if the product is a medical device.
- Approved Device – Approved Use
- Device is FDA approved/cleared for marketing in the United States.
- The results of the investigation are NOT intended to be reported to FDA as a well-controlled study in support of a new indication for use or intended to be used to support any other significant change device labeling.
- The investigation is being used in accordance with the indications in the approved labeling and does NOT involve a new device indication such as a new population, condition, area of the body, or significant design change.
- Diagnostic Device (In vitro or otherwise)
- NON-invasive
- does NOT require invasive procedure that presents risk
- does NOT introduce energy into a subject
- will NOT be used available for use as a diagnostic without confirmation by another medically established procedure or product
results from study device will NOT be used to make clinical decisions
- Consumer preference (not collecting for safety or effectiveness data)
- Custom Device
- Study is EXEMPT because the FDA or commercial sponsor has provided documentation indicating that IDE is not required. Attach applicable documentation
- FDA Approved Humanitarian Use Device (HUD) used solely for clinical purposes.
NSR/SR
- Non-Significant Risk (NSR) Device Study
- While NSR device studies do NOT require an IDE submission to FDA, they are subject to “abbreviated” FDA regulatory requirements and sponsor responsibilities. Describe or attach documentation to justify NSR designation.
- Note: The full convened IRB must concur with an NSR designation. You may be asked to contact the FDA for confirmation or consultation.
- Significant Risk (SR) Device Study – conducted under the full requirements with formal IDE submitted to and approved by FDA. Complete IDE information above once available.
- Unknown
Attach applicable device documentation
(e.g., Manufacturer information; sponsor protocol; approved labeling; indications for use; FDA correspondence (e.g., validation of IDE#); contraindications; precautions, warnings; etc.). For Humanitarian Use Devices (HUD) attach manufacturer labeling or patient information packet available from FDA HUD Listing. Attachments here will automatically be assigned the "Other Device Documentation" document type.
FDA Contacts:
If you have questions, you can contact:
- Office of Product Evaluation and Quality (OPEQ)
- the division of Industry and Consumer Education at 800-638-2041 or DICE@fda.hhs.gov
To obtain a written study risk determination from the FDA, follow the procedures laid out in their Q-Submission Program Guidance and eCopy Program Information.
Definitions
Humanitarian Use Device (HUD) [21 CFR 814] is a device that is intended to benefit patients in the treatment and diagnosis of diseases or conditions that affect or is manifested in fewer than 4,000 individuals in the United States per year. The statute and the implementing regulation (see 21 CFR 814.124(a)) require IRB review and approval before a HUD is used in a facility. For use of a HUD in emergency, off-label/compassionate, and investigation situations refer to the UK Humanitarian Use Device SOP and the IRB Medical Devices: Humanitarian Use Devices. For more information on HUDs and Humanitarian Device Exemptions (HDE) Regulations see the FDA HDE Regulation Question and Answers guidance. Treatment IDE [21 CFR 812.36] is a device that is not approved for marketing may be under clinical investigation for a serious or immediately life-threatening disease or condition in patients for whom no comparable or satisfactory alternative device or other therapy is available. During the clinical trial or prior to final action on the marketing application, it may be appropriate to use the device in the treatment of patients not in the trial under the provisions of the FDA Expanded Access program as a Treatment or Compassionate Use. For guidance, see the Special Requirements for UK Medical Device Clinical Investigations, Compassionate Use, and Treatment IDE SOP.
Additional Guidance Materials:
