What is an investigational medical device?
An investigational medical device is one that is the subject of a clinical study designed to evaluate the effectiveness and/or safety of the device.
All clinical investigations of devices must have an approved IDE (Investigational Device Exemption) from the FDA or be exempt from the IDE regulations before beginning a clinical investigation of a significant risk device.
Who Must Apply for an IDE?
The sponsor of the clinical trial is responsible for submitting the IDE application to FDA and obtaining Institutional Review Board (IRB) approval before the study can begin. Foreign companies wanting to conduct a clinical study in the U.S. MUST have a U.S. sponsor. Under certain circumstances, the clinical investigator may wish to submit an IDE and would, therefore, also act as the sponsor of the study.
When is an IDE from the FDA not required?
Studies involving devices that are considered to be a non-significant risk (NSR): An IDE from the FDA is not needed for research when the sponsor provides a brief explanation of why the device is NSR and the IRB agrees with the sponsor’s explanation.
How are investigational medical devices classified?
There are two possible classifications for investigational medical devices:
- Significant Risk (SR) or
- Non-Significant Risk (NSR)
What is the Difference between Significant and Non-Significant Risk Devices?
The distinctions between the two device risk categories are:
- An SR device poses a “potential for serious risk to the health, safety, or welfare of a subject.” Such devices may only be studied under an Investigational Device Exemption (IDE) granted by the FDA.
A device is SR (and requires an IDE) if it:
- is intended as an implant, or
- is purported or represented to be for use in supporting or sustaining human life, or
- is for the use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health; or
- otherwise presents a potential for serious risk to a subject’s health, safety, or welfare.
- Non-significant risk devices do not meet the above definition. The assessment of whether or not a device study represents an NSR is initially made by the sponsor/investigator. The IRB will then determine if the NSR designation is appropriate. If the IRB disagrees with the NSR claim, it will require the sponsor/investigator to submit an IDE application to the FDA.
Exemption for Devices
If something is determined to be a device, one must then determine if the device is exempt from FDA regulations.
A custom device is exempt unless the device is being used to determine safety or effectiveness for commercial distribution.
- A legally marketed device when used in accordance with its labeling
- A diagnostic device complies with the labeling requirements and if the testing is noninvasive, does not require an invasive sampling procedure, does not introduce energy into a subject, and does not penetrate or pierce the skin.
- Consumer preference testing, testing of a modification, or testing of a combination of devices if the devices are legally marketed) [that is, the devices have an approved PMA, cleared Premarket Notification 510(k), or are exempt from 510(k)] AND if the testing is not for the purpose of determining safety or effectiveness and does not put subjects at risk;
- A device intended solely for veterinary use;
- A device shipped solely for research with laboratory animals and contains the labeling “CAUTION – Device for investigational use in laboratory animals or other tests that do not involve human subjects.”
- A custom device
- Necessarily deviates from devices generally available or from an applicable performance standard or premarket approval requirement in order to comply with the order of an individual physician or dentist;
- Is not generally available to, or generally used by, other physicians or dentists;
- Is not generally available in finished form for purchase or for dispensing upon prescription;
- Is not offered for commercial distribution through labeling or advertising; and
- Is intended for use by an individual patient named in the order of a physician or dentist, and is to be made in a specific form for that patient, or is intended to meet the special needs of the physician or dentist in the course of professional practice.
- Computer programs may be medical devices – it depends on the specific program and exactly what it does.
- Medical Mobile Apps: Mobile medical applications (apps) may be considered a device.
University of Virginia: https://research.virginia.edu/irb-hsr/investigational-medical-devices
John Hopkins Medicine: https://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/guidelines/devices.html#device2