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Indiana University School of Medicine
Indiana University Office of Clinical Research
Roadmap

Requirements for Device, Equipment, and Software in Research

This section describes requirements for studies conducted in an IU Health facility involving one or more of the following:

  • An investigational medical device
  • Approved devices which may or may not be used in IU Health clinical spaces.
  • Study-required equipment that is NOT used in clinical spaces currently (ex. Sponsor provided EKG machine)
  • Humanitarian Use Devices

The IU IRB website offers many resources to help you determine the level of risk for an investigational device and Humanitarian Use Device (HUDs). If the device has been developed by an IU or IU Health Team member, please refer to the Consultation with CTSI for IND/IDE Submission page.

Investigational Medical Devices

A medical device is considered investigational if either condition applies: a) device is not approved for marketing in the United States OR b) device is approved for marketing but is being clinically evaluated for a new indication.

An 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 PMA (Premarket Approval).

  • FDA provides IDE approval for Significant Risk devices.
    • Category A: Experimental: a device for which ‘absolute risk’ of the device type has not been established (that is, initial questions of safety and effectiveness have not been resolved) and the FDA is unsure whether the device type can be safe and effective.”
      • Must be provided for free to subject
    • Category B: Nonexperimental/Investigational: a device for which the incremental risk is the primary risk in question (that is, initial questions of safety and effectiveness of that device type have been resolved), or it is known that the device type can be safe and effective because, for example, other manufacturers have obtained FDA premarket approval or clearance for that device type
      • With CMS approval, may be billed to third party payor OR sponsor may provide for free

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device.

  • Class I – Low to moderate risk
  • Class II – Moderate to high risk

For novel low-to-moderate risk medical devices with no predicate device. FDA will assign Class.

Medical devices intended to benefit patients in the treatment or diagnosis of diseases or conditions that affect or are manifested in not more than 8,000 individuals in the United States per year.

  • Requires FDA to approve Humanitarian Device Exemption (HDE)

A medical device that is approved within the United States and is not being studied to obtain additional approval for a new indication or marketing. Examples of this type of research include Phase IV research studies mandated by the FDA to collect real world evidence or comparative effectiveness research of a device versus another device or treatment.

  • All investigational devices utilized as part of a research study to be registered in the Device and Equipment REDCap form. This allows IU Health’s Clinical Trial Research Charge (CTRC) team to review whether a new charge code will need to be created.
  • Any equipment or medical devices supplied by either IU (for investigator initiated studies) or the sponsor to be registered in the Device and Equipment REDCap form.
  • Research Device and Equipment Registration Form
  • Please see checklist to determine the level of review required.

 

If the device or software will be connected to an IU network (versus an IU Health network), there may be additional reviews. For example, in IUSCCC, the CTO HIPAA Liaison may also have to review the device and access to the IU Network. Your first step would be to reach out to the appropriate data steward for guidance. If you are unsure where to start, first reach out to the Research Data Steward.

IU Simon Comprehensive Cancer Center (IUSCCC) Additional Information

Device Research involving oncology patients or screening/diagnosis of cancer must be reviewed by IU Simon Comprehensive Cancer Center’s SRC (scientific review committee).

For questions, contact the CTRC team:  clinicaltrials@iuhealth.org, OCR Financial Compliance Team: ocrfin@iu.edu or for general questions about IU Health processes: clinicalresearchsupport@iuhealth.org.

Devices and Required Equipment in Research is only one component of study activation. Additional requirements should be reviewed using the Clinical Research Roadmap.