Requirements for Device, Equipment, and Software in Research

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.

At a minimum, IU Health will require the Clinical Trial Research Charge (CTRC) team to review the type of equipment, device or supply when these will be used within research studies at an IU Health facility. 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.

• Link to FDA Device Regulations
• Link to FDA Guidance documents