Investigational Device Exemption (IDE) Resources


The following information is provided to guide sponsor-investigators (SI) through the Investigational Device Exemption (IDE) process. Information below is provided only as guidance. Specific questions and inquiries regarding IDE Applications should be addressed to the FDA.

An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. Clinical studies are most often conducted to support a Food and Drug Administration (FDA) Premarket Application (PMA). Only a small percentage of 510(k)s require clinical data to support the application. Investigational use of a device also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated.

Please review our flowchart on the IDE process for more information. The federal regulations for IDEs are found at 21 CFR 812.

All clinical investigations of medical devices require IRB review and approval.

IDE Regulatory Requirements 

FDA 21 CFR 812 is the US federal regulation that covers IDEs. This regulation details procedures for the conduct of clinical studies with medical devices including applications, responsibilities of sponsors and investigators, labeling, records, and reports.

Investigational devices covered under the IDE regulation are subject to different levels of regulations depending upon the level of risk (i.e., significant risk (SR) and non-significant risk (NSR) device studies).

  • Studies with significant risk (SR) devices must follow all IDE regulations under 21 CFR 812, must have an FDA approved IDE application, and an IRB approval before the start of the investigation.
  • Studies with non-significant risk (NSR) devices only need to follow abbreviated IDE regulations under 21 CFR 812.2 (b), and require only IRB approval before the start of the investigation. 
  • Studies with devices can also be exempt from the IDE regulations under 21 CFR 812.2(c).

When is an IDE Application Required? 

A sponsor or sponsor-investigator is required to submit an IDE application to the FDA if:

  • The sponsor or sponsor-investigator intends to use a significant risk device in an investigation;
  • The sponsor or sponsor-investigator intends to conduct an investigation that involves an exception from informed consent under 21 CFR 50.24; or
  • FDA notifies the sponsor that an IDE application is required for an investigation.

The following steps summarize the IDE determination process:

Step 1. Is the device subject to IDE regulations?

If the ultimate goal of the device under investigation is to diagnose, cure, treat, mitigate, or prevent disease, then once any human subjects or human specimens are used, regardless of the phase of the study or the amount of data being collected, IDE regulations apply, unless the study is exempted from IDE regulations based on 21 CFR 812.2(c).

The use of human subjects (or human specimens) is what determines the transition to IDE, and starts the process of having to determine the risks to the human subjects. It may be determined that devices or assays are exempt from the IDE regulation, but because of variations in devices and their uses, this determination may only be appropriately made on a case-by-case basis.

Step 2. Is the device Exempt from IDE regulations?

The following categories of devices are exempt from IDE regulations:

  • devices in commercial distribution before 5/28/76
  • devices determined by FDA to be 'substantially equivalent' to a device in commercial distribution before 5/28/76
  • diagnostic devices that:
    • are noninvasive,
    • do not require an invasive sampling procedure that presents significant risk,
    • do not introduce energy into a subject, and
    • are not used as a diagnostic procedure without the confirmation of another medically established diagnostic product or procedure
  • devices used for consumer preference testing or for any test that is not intended to determine safety or effectiveness and does not expose subjects to risk
  • devices exclusively used for veterinary indications
  • devices to be shipped exclusively for research on laboratory animals
  • custom devices unless these are used to assess safety or effectiveness for commercial distribution

Studies that are exempt from the requirements of IDE regulations are not exempt from the requirements for IRB review and approval. Even though the majority of low risk devices and in vitro diagnostics (IVDs) are exempt, when a device or assay is used to determine eligibility for a clinical study, or used for a novel indication, and the results are not confirmed with another medically established diagnostic product or procedure, IDE regulations apply.

Device studies that are exempt from IDE requirements still require IRB approval. With your submission materials in eIRB, include the Appendix for Devices to document the specific exemption category that applies to the device.

Step 3. Does the non-exempt device pose a significant risk (SR) or non-significant risk (NSR) to human subjects?

It is the responsibility of the sponsor or sponsor-investigator to make the initial risk assessment; and depending on the outcome, either the FDA makes the final significant risk (SR) or the IRB makes the final non-significant risk (NSR) determination.

The criteria outlined in (21 CFR 812.3 (m)) are used to make the SR determination, based on whether or not the device:

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

If the device meets the definition above, it is considered significant risk (SR). If the device does NOT meet the definition above, it is considered non-significant risk (NSR).

An NSR device is considered to have an approved IDE application, therefore no application needs to be filed with the FDA. Please refer to our guidance on Abbreviated IDE Requirements for more information about NSR device requirements.

However, if an IRB determines the study is significant risk, the sponsor or sponsor-investigator must notify the FDA in writing. The study may not begin until the FDA approves the study or provides an NSR determination.

Pre-IDE Process

Sponsors of an SR study are encouraged to review the Contact FDA – Device Guidance to obtain further guidance prior to the submission of an IDE application to the FDA. This will be especially beneficial to new sponsors who have not previously had contact with the agency and for sponsors proposing to study new technologies or new uses for existing technologies. The FDA’s Pre-IDE Program is primarily designed to benefit the IDE sponsor.  By allowing the sponsor to obtain early FDA input on selected (by the sponsor) sections of the IDE application, the FDA hopes that the initiation of clinical trials will be facilitated. This communication may take the form of telephone conference calls, videoconferences, or face-to-face discussions.

The sponsor should contact the Office of Device Evaluation (ODE) reviewing division directly or may contact the FDA IDE staff for assistance:

IDE Staff
Investigational Device Exemptions Program
Office of Device Evaluation
Center for Devices and Radiological Health
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Telephone 301-796-5640

Please review the latest FDA Guidance for IRBs, Clinical Investigators, and Sponsors for more information.  

IDE Application Guidance

The following are required items for IDE Applications to the FDA:

  • The IDE holder’s name and address
  • A report with all prior investigations of the device and a summary of the investigational plan.
  • A description of methods, facilities and controls used in the manufacture, processing, packing, storage, and, if applicable, installation of the device.
  • An example of the agreement to be signed by the investigators and a list of the names and addresses of all investigators.
  • A statement certifying that all investigators participating in the study will sign the agreement and that no investigator will take part in the study before signing the agreement.
  • An IRB list with the name, address and chairperson of each IRB that will review the investigation and a certification of IRB study-related action.
  • If the device will be sold, the amount to be charged for the device and a rationale of how its sale does not amount to commercialization of the device.
  • The IDE Sponsor-Investigator writes the IDE Application.

 The IDE Application submission to the FDA must also include:

  • IDE Cover Letter
  • Investigators Certification of Financial Interest
    • Form FDA 3674 
    • eCopy of submission
      • An electronic copy (eCopy) is an electronic version of your medical device submission created and submitted on a compact disc (CD), digital video disc (DVD), or a flash drive. An eCopy is accompanied by a paper copy of the signed cover letter. 
      • Please refer to FDA guidance on eCopy submissions.

Submitting an IDE Application to the FDA

On the outer packaging of the submission (e.g., the FedEx label), identify the contents as "Initial IDE Application," "IDE Supplement," etc. The same identification should appear in the “RE:” section of the cover letter. Keep a copy of the courier receipt. Track the shipment on the courier website for confirmation of delivery. File a PDF copy of the delivery confirmation with the PDF copy of the signed submission.

FDA will reply to the submission with an acknowledgement letter containing:

  • the date of receipt of the IDE application;
  • the IDE number assigned to your application; and
  • the name of the project manager to address in future submissions under the IDE.

An IDE application is considered approved thirty (30) days after it has been received unless FDA informs the sponsor otherwise. An IDE may be approved, approved with conditions, or disapproved. It is advised that you obtain written confirmation (email or fax) that the FDA review has been completed and that the study may proceed.

For more detailed information, please review FDA Application guidance. Review the IDE Application Checklist to ensure it contains all pertinent information.

Maintaing the IDE

IDE sponsor or sponsor-investigators are required under 21 CFR 812.150 to submit the following reports:

  • Unanticipated Adverse Device Effects (UADE): A UADE Report consists of a completed Form FDA 3500A and an analysis of the event in a cover letter, submitted to FDA and all reviewing IRBs and investigators within ten (10) working days after the sponsor first receives notice of the adverse effect.
  • Withdrawal of IRB Approval: Submitted to FDA and all reviewing IRBs and participating investigators within five (5) working days after receipt of notice of the withdrawal of IRB approval of an investigation (or any part of an investigation).
  • Withdrawal of FDA Approval: Submitted to all reviewing IRBs and participating investigators within five (5) working days after receipt of notice of any withdrawal of FDA approval.
  • Current List of Investigators with Addresses: Submitted to FDA every six (6) months.
  • Progress Reports: Submitted to FDA and all reviewing IRBs at regular intervals and at least yearly.
  • Recalls and Device Disposition: Submitted to FDA and all reviewing IRBs within thirty (30) working days after receipt of a request to return, repair, or dispose of any unit of an investigational device. The report must state why the request was made.
  • Final Report: For a significant risk device, the sponsor must submit a final report notifying FDA and all reviewing IRBs within thirty (30) working days of the completion or termination of the investigation. The sponsor must also submit a final report to FDA and all reviewing IRBs and participating investigators within six (6) months after the completion or termination of the investigation.  
  • Use of a Device without Informed Consent: Submitted to FDA within five (5) working days after receipt of notice of such use.
  • SR Device Determination: Submitted to FDA within five (5) working days after determination by an IRB that the device is a SR device and not an NSR device as the sponsor had proposed.
  • Other Reports: Accurate, complete, and current information about any aspect of the investigation upon request from FDA or the reviewing IRB.


The following definitions appear in the Investigational Device Exemption regulations 21 CFR 812.3:

FDA is the United States (US) Food and Drug Administration in charge of overseeing Title 21 Federal Regulations.

Indications for use describes the disease or condition the device will diagnose, treat, prevent, cure or mitigate, including a description of the patient population for which the device is intended.

is the general purpose of the device or its function, including its indications for use.

Investigation is a clinical investigation or research (study/trial) involving one or more subjects to determine the safety or effectiveness of a device.

Investigational device is a device, including a transitional device, that is the object of an investigation.

Investigator is an individual who actually conducts a clinical investigation (i.e., under whose immediate direction the investigational device is administered, dispensed to, or used involving a subject). In the event the investigation is conducted by a team of individuals, "investigator" refers to the responsible leader of the team.

  • Sponsor is a person or other entity that initiates but does not actually conduct the investigation. An entity other than an individual (e.g., a corporation or an agency) which uses one or more of its own employees to conduct an investigation that it has initiated is considered to be a sponsor, not a sponsor-investigator, and the employees are considered to be investigators. FDA requires that the sponsor of an IDE must be located in the United States (see 21 CFR 812.18).
  • Sponsor-investigator is an individual who both initiates and actually conducts, alone or with others, a clinical investigation (i.e., under whose immediate direction the investigational device is administered, dispensed, or used). For example, a clinical investigator can sponsor his/her own study, in which case they become a sponsor-investigator. The term does not include a corporation or agency. The obligations of a sponsor-investigator include those of an investigator and those of a sponsor.
  • Subject means a human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used, or as a control. A subject may be in normal health or may have a medical condition or disease.

Not finding what you're looking for? Try searching all research-related FAQs.

As part of the system conversion, all current access and roles with the exception of Lead-Unit pre-approval will be migrated over to the updated system environment. There is no action required on your part.

You will have access to items in the 'Proposals not routing' card on the dashboard if you:

  • initiated the proposal document
  • are included as Personnel on the project (PI, Co-I, Key Person)
  • are provided viewer, editor, or aggregator privileges through the Access tab of the proposal
  • are provisioned to view or approve proposals for any unit included in the proposal 
  • are added as an Ad Hoc with an Acknowledge, FYI, or Approve action

You will be able to look up Negotations by department in the current version of UAccess Research (v. 5.2.1) until Thursday, January 20th before 5pm. After that, the old system will go dark. During system conversion, all negotiation records will be transferred over to the updated UAccess Research system. You will be able to look up Negotiations by department in the updated version of UAccess Research (Kuali SaaS) after go-live on Tuesday, January 25 after 8am. 

To search for Negotiations by department in the updated version of UAccess Research, click on the Common Tasks button in the left-hand navigation panel. Find the Negotiation card and click Search Negotiation. Enter the Unit Number in the appropriate field and click search. You will only be able to open a Negotiation if you are provisioned to be able to do so for that unit. 

Yes. The content included/shown on the Medusa page is the same in the updated UAccess Research System. It just has a different look and feel.

You will still have the options of displaying Proposal > Award where the Proposal is the top item and all awards, negotiations, and subawards associated with the proposal fall under it, or Award > Proposal where the Award is the top and all proposals, negotiations, and subawards associated with the award fall under it. You can expand each item by clicking on it, and have the option to open each item directly from the Medusa page (as long as you are provisioned to view that item). 

Yes. Your Automatic Refresh Rate, Action List Page SizeFields DisplayedColor Coding for Route Status, and Email Notification Preferences will all be migrated over to the updated UAccess Research system.

No. Campus users may only create Proposal Development documents. Only Sponsored Projects, the Office of Research Contracts, and UAHS Contracts will be able to create Institutional Proposals, Negotiations, Awards and Subawards. You will receive an error message if you attempt to create any of these document types and do not have the appropriate provisioning. 

There are a few potential explanations: 

  1. You are searching for items you are not provisioned for. The Search Records feature only displays search results you have access to. You have access to items where you were the document initiator, you were included as personnel on the document, you were provided a specific viewer, editor, or aggregator role on the document, you are provisioned to view or approve documents for any of the included units, or you were added as an Ad Hoc with an Acknowledge, FYI, or Approve action. If you would like to see all search results, you will need to use the specific search functions for Awards, Negotiations, Institutional Proposals, Proposal Development, and Subawards in the Common Tasks section. 
  2. Your search parameters are too narrow. You may need to broaden your search terms to capture additional items. The more search terms you combine (Lead Unit, PI, Title, Deadline Date, etc.), the narrower your results will be. By searching for broader categories, you will obtain more results. 
  3. You are using an incorrect parameter for a given search term. You may need to look in the All Links section for the specific term to find out what possible parameters are and the specific spelling, spacing, and punctuation. 

Click on Common Tasks in the left-hand navigation panel. Find the Proposal Development card and select Create Proposal

See the Create and Save a New Proposal video for step-by-step instructions. Be aware that there are additional videos for completing each section of the Proposal Development document and submitting the proposal to routing for review, approval, and submission. 

Both the Proposal number and Document number were available and acceptable under UAR 5.2.1, however the Proposal number was more difficult to locate so the Document number became the preferred way to reference a proposal. In the updated UAR SaaS environment the Proposal number is more prominent and easier to locate, but SPS will still accept both numbers when referencing your proposal. 

Title case is used to provide consistency in the system and in reporting. Please do not use ALL CAPITALS or all lowercase in proposal/project titles. 

In title case, major words are capitalized and most minor words are lowercase. If your title uses alternate capitalization where a letter other than the first letter of a word is used in the acronym and requires special emphasis, please capitalize as you feel is best indicated for your acronym. 

Major words include nouns, verbs, adjectives, adverbs, pronouns, and all words of four letters or more.

Minor words include short (i.e., three letters or fewer) conjunctions, short prepositions, and all articles. 

In title case, capitalize the following words in a title or heading:

  • the first word of the title or heading, even if it is a minor word such as “The” or “A”
  • the first word of a subtitle
  • the first word after a colon, em dash, or end punctuation in a heading
  • major words, including the second part of hyphenated major words (e.g., “Self-Report,” not “Self-report”)
  • words of four letters or more (e.g., “With,” “Between,” “From”)

Use lowercase for minor words that are three letters or fewer in a title or heading (except the first word in a title or subtitle or the first word after a colon, em dash, or end punctuation in a heading):

  • short conjunctions (e.g., “and,” “as,” “but,” “for,” “if,” “nor,” “or,” “so,” “yet”)
  • articles (“a,” “an,” “the”)
  • short prepositions (e.g., “as,” “at,” “by,” “for,” “in,” “of,” “off,” “on,” “per,” “to,” “up,” “via”)

Yes. As long as an original document was uploaded as an attachment prior to routing, the proposal initiator can replace the attachment with an updated/revised version by navigating to the Attachments section and clicking the Details button on the right side of the page next to the desired attachment. The initiator will then choose the new file to upload and click Save. 

In some proposals on the Dashboard you will see a small red Compliance pill:  . There is no action required on these proposals. It's simply a visual indicator that the project involves Human Subjects or live Vertebrate Animal Subjects. If you click on the Compliance pill you will see what Type (Animal Subjects or Human Subjects) and Status (Exempt, Not Yet Applied, Pending) were included in the proposal. 

Key Persons should always have been added to the proposal and included in routing for review and approval of their role and commitment on the project. Unit Details had to be added manually and were not included or required for Key Persons previously and they were not included in Award Credit and F&A Revenue allocations except in special circumstances.

With this update, the Key Person's HR Home Unit will automatically be pulled in and they default to being included in Credit Allocations. You may simply enter 0% for Award Credit and F&A Revenue allocation for these individuals, or you may uncheck the box "Include in Credit Allocation" to remove them from allocations altogether. 

UArizona will receive security updates and new system features for UAR on a continuous basis.  The standard UAR system maintenance windows are:


  • Daily from 7:00 PM - 8:00 PM MST
  • Sundays from 6:00 AM - 10:00 AM MST

If you choose to work in UAR during the maintenance periods, please save your work often.  While the system updates, you may have an interruption in service and unsaved work will be lost.

The JoinCostShare node will always display in the Current Route Node(s) regardless of whether a budget is included with cost share units as it allows the cost share workflow functionality. 

The Search Records feature will return results excluding disapproved and cancelled documents, while the individual searches in Common Tasks (Awards, Negotiations, Proposals, Subawards) will return all results, including disapproved and cancelled documents. 

Additionally, the Search Records feature is limited by your access/role, whereas the individual searches are not. Search Records will only return results for items you have access to, either because you created the document, you were provided an access role to the document, you are listed as personnel on the document, or you have been provisioned as a unit viewer/approver. You should be able to open any document that appears in your Search Records results. Individual searches in Common Tasks (Awards, Negotiations, Proposals, Subawards) will return all results, regardless of access, however you will only be able to open items for which you have access.  

A recall or return for edit action removes any pending workflow Approval and Ad Hoc FYI/Acknowledge/Approve actions and basically resets routing. 

If you are using an Ad Hoc FYI or Acknowledge to track a proposal in your Action List once it leaves your "Proposals not routing" card, you can take the Ad Hoc action and it will transfer to your Action List Outbox, where it will remain even if the proposal is recalled or returned for edit. 

To turn on our Action List Outbox:

  • From your Action List, click the preferences button in the upper right corner.
  • Ensure Use Outbox is checked in your Fields Displayed in Action List
  • Be sure to click the save button at the bottom of the page!


At times your Action List Outbox may get very large and may take more time to load and process pages. You can delete older items if and as desired to pare down your Outbox and make it run more efficiently. 

To delete old items from your Action List Outbox: 

  • From your Action List, click Outbox.
  • Check each item you wish to delete.
  • Click delete selected items.

We are working with Kuali to determine what we can do to improve these notifications to be clearer/more in line with a "Return for Edit". In the meantime, you can create a rule in Microsoft Outlook which marks the message as high importance and flags the message for follow-up that same day. 

  1. Create Rule - In Outlook, Rules is in the top toolbar under the Move Section. 

  1. Mark initial parameters and then select Advanced Options…

  1. Select any additional parameters or refine existing

  1. Select actions Mark it as importance and Flag message for follow up at this time. Then if you click on the hyperlinked text follow up at this time you can select Follow up Today and importance you can select high importance.

  1. Provide exceptions to refine or ensure you’re not applying the action to replied/forwarded items (when others are asking question) or copied items (where you’re not the main recipient).
    Perhaps “except if the subject contains certain words” and include RE: and FW: as a filter criteria? Would help filter anything that was forwarded to them from others with a question.


  1. Name the rule and then check “Run this rule now” to run the actions against anything meeting those criteria currently in their box.

There is an overnight process that runs behind the scenes in UAccess Research (UAR) to make sure dashboard cards like “Proposals not routing,” “Proposals routing to me” and “Proposal Workload Assignments” are updated with the latest changes. This process usually begins a little after midnight AZ time. Proposals approved after midnight may not be reflected in the UAR dashboard cards that day, they will update with the next overnight update.

If a looming deadline cannot wait for the next overnight update, please email Sponsored Projects Services (SPS) at to request assistance. Include the Proposal number or UAR document number in the request.

If you work with an investigator who has a preferred name in addition to their primary legal name, and who may have had proposals, awards, negotiations or subawards under both names, use the vertical line ‘or’ operator, “|”, in lookup screens accessed via Common Tasks in the UAR left hand navigation pane. This will allow a search for all names the person might have used in past records.

In the past, UAR only populated a person’s legal/primary name as it was entered into the UAccess Employee system. As of the January 25, 2022 UAccess Research (UAR) system update, both primary legal name and preferred name are brought into UAR, with the default being preferred name. As a result of added flexibility, people who have a preferred name or who have changed their name over time may have older records under a different name.

Example: john den|ja*den finds John R Den, Johnna Alden, OR Jack Den, Jason Hayden.


Lookup Wildcards



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If used repeatedly, an && is assumed. Ex: !1490!1491 is like !1490&&!1491

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? matches one character.  
* matches any number of characters.
?, * are used even if ! is used, but not if any of range operators below are used.


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Greater than

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Less than

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