Research with Device Products
Research involving the use of devices is complex and varied. Some protocols use marketed devices that are not generally considered to be medical devices, such as a Fitbit or virtual reality. Some devices are simply used to collect research data. On the other end of the spectrum, a device may be implanted into a participant. Some device use involves the return of results to participants (e.g., lab tests, MRIs, ECGs, etc.) while other device uses do not. Additionally, an algorithm, software or even artificial intelligence may be considered a device on a protocol, contingent upon its impact on prospective participants.
Considerations for Research with Devices
Research with Devices
When evaluating a protocol, the IRB considers the following seven questions. Click here for a visual representation.
- What type of device is being used? (i.e., assay, MRI, software, etc.)
- How is the device used on the submitted protocol?
- Is it being used according to the definition of a medical device?
- If used as a medical device, is it the subject of the investigation?
- Is the device marketed? If yes, is it being used on label or being used in an investigational manner?
- Is the protocol subject to IDE regulations (requires an IDE) or is it exempt from IDE regulations (does not require an IDE)?
- If the protocol is subject to IDE regulations, what is the risk of the device, as used on the protocol? Device risk determinations are made on a protocol basis, not a device basis.
FDA Definition of a Medical Device
A medical device is:
- Recognized in the official National Formulary of the United States Pharmacopoeia; OR
- Intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease or other conditions; OR
- Intended to affect the structure or function of the body AND
- Does not achieve its primary intended purposes through chemical action within or on the body AND is not dependent upon being metabolized for the achievement of any of its primary intended purposes.
Exemption from IDE Regulations Guidance
An application to use a device in a study in order to collect safety or effectiveness data is called an investigational device exemption (IDE). The FDA regulations detailing these requirements also detail certain categories of research that do not require an IDE (i.e., exempt from IDE regulations). Click below for detailed guidance on the applicability of IDE regulations entitled, Exemption from IDE Regulations Guidance.
Requesting an Exemption from IDE Regulations Determination
Penn Medicine Office of Clinical Research Regulatory Services
Penn Medicine Principal Investigators are recommended to request an exemption determination from the Office of Clinical Research Regulatory Services. OCR Regulatory will conduct exemption determinations for any product type.
IRB
Non-Penn Medicine Principal Investigators may request an exemption determination from the IRB. In order to request an exemption determination, submit the Research with Devices Form with your initial application.
FDA
Any Principal Investigators may seek an exemption determination directly from the FDA. See Additional Information section below.
Protocols that Require an IDE
If the protocol is not exempt from the IDE regulations, the IRB must determine the risk of the device as used on the protocol. NOTE: Risk determinations are not definitive and may change, should unanticipated adverse device effects occur, or evidence suggests that the risk of the device is greater or lower than originally anticipated.
Non-Significant Risk Protocol: Use of the device on the protocol does not meet the definition of significant risk.
Significant Risk Protocol: Use of an investigational device that presents a potential for serious risk* to the health, safety or welfare of a subject due to its intended use AND is used:
- As an implant OR
- For supporting or sustaining human life OR
- Of substantial importance in diagnosing, curing, mitigating, or treating disease or otherwise preventing impairment of human health OR
- Presents some other serious risk to patient’s health, safety, or welfare
Serious Risk
“Serious risk” is considered to be any risk that would be considered a serious adverse event.
- A serious adverse event is defined as: any risk associated with the device that may adversely affect the health or safety of a participant that:
- Is life-threatening, or cause death, or
- Causes hospitalization, disability or permanent damage, congenital anomaly/birth defect, or
- Requires a medical / surgical intervention to prevent permanent impairment or damage, or
- Is any other serious medical event that may adversely affect the safety or welfare of subjects.
- Devices may be considered to present serious risk in the following scenarios:
- The device is a novel device with no predicate (a predicate is a medical device that may be legally marketed in the U.S. and is used as a point of comparison for new medical devices)
- A device used for an indication not previously evaluated by the research team, the FDA, or peer review, without medical and or scientific rational justifying the safety of the device(s)
Additional Information
Submitting a Request for an Exemption or Risk Determination to FDA
Unsure about risk of the device? Sponsors or sponsor-investigators can submit a Study Risk Determination Q Submission to the FDA. The only required documents consist of: Cover letter, device description, and protocol. A full IDE application is NOT required. FDA will determine whether the protocol qualifies for exemption and issue a determination letter. If the protocol is not exempt, FDA will provide a risk determination. Please review the FDA Guidance linked below.
Investigational Plans
IDE protocols require an investigational plan. See below for guidance on investigational plans. For guidance on submitting an IDE to the FDA, please contact the PSOM Office of Clinical Research, Regulatory Support Team.
Regulatory Support
Treatment of a Patient with an Unapproved Device Product
An unapproved product can be administered for treatment purposes under the FDA’s expanded access program, if certain criteria are met. For more information, please click below.
Requirements for Conducting Clinical Investigations
Requirements for Abbreviated IDE Holders
For guidance on the Requirements for Abbreviated IDE Holders please contact the PSOM Office of Clinical Research, Regulatory Support Team.
PSOM Policies and Procedures
Perelman School of Medicine policies and procedures apply to device research when research involves Penn Medicine patients and / or PSOM faculty. This includes research that is led by Faculty from non-Penn Medicine schools such as School of Nursing, Engineering, or SAS. Questions about these policies and procedures can be directed to the Office of Clinical Research.
PI Acknowledgement of Responsibilities in Biomedical Research
The Principal Investigator is responsible for:
- Ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations;
- Protecting the rights, safety, and welfare of subjects under the investigator’s care; and
- The control of drug(s) or device(s) used in the investigation.
The Principal Investigator’s Acknowledgement of Responsibilities document has been developed as a reminder of the responsibilities of the principal investigator in a clinical investigation.