To launch a US medical device study, an approved Investigational Device Exemption (IDE) may be required. 21CFR 812 is part of the Code of Federal Regulations (CFR) containing the procedures and requirements governing the conduct of clinical research of devices. If needed, FDA clearly describes the IDE application format. According to the regulations of 21 CFR 812, device studies are categorized into three types:
- Exempt studies: these studies are exempt from the requirements of 21 CFR Part 812. Examples of exempt studies include diagnostic device studies (e.g., in vitro diagnostic studies), consumer preference testing, and testing of a device modification.
- Significant risk (SR) device studies: these studies require an approved IDE (Investigational Device Exemption) from the FDA and must comply with the regulations at 21 CFR 812.
- Nonsignificant risk (NSR) device studies: these studies must meet the abbreviated IDE requirements at 21 CFR 812.2(b).
The FDA regulations state all clinical investigations of devices must have an approved IDE or be exempt from the IDE regulations.
The FDA definition of a sponsor-investigator means an individual who both initiates and actually conducts, alone or with others, an investigation, that is, under whose immediate direction the investigational device is administered, dispensed, or used. The term does not include any person other than an individual. (21 CFR 812.3 (o)),
The sponsor (sponsor-investigator) is responsible for submitting an IDE application to FDA and ensuring IRB review and approval are obtained. (21 CFR 812.40).
Consider these questions to ascertain if your study requires an IDE:
1. Is the study an investigation?
The FDA definition of an investigation means a clinical investigation or research involving one or more subjects to determine the safety or effectiveness of a device. (21 CFR 812.3 (h)).
2. Is the product a Medical Device?
The 2017 FDA Guidance “Classification of Products as Drugs and Devices and Additional Product Classification Issues” describes how the agency classifies devices vs drugs.
3. Is the study exempt from IDE regulations?
Refer to the following documents to determine if the device study is exempt from IDE regulations (no IDE required).
Importantly, IRB review and approval is still required for IDE exempt studies.
4. Is the device study classified as a Significant Risk (SR) or Nonsignificant Risk (NSR) study?
If the study does not meet the exemption criteria (21 CFR 812.2 (c)), the sponsor (sponsor-investigator) is required to make an initial assessment of whether the study is a Significant Risk (SR) or Nonsignificant Risk (NSR) device study. Below is an overview of the approval process for these types of device studies:
Significant Risk (SR) Study Approval Process:
- Requires IDE submission and FDA approval prior to study initiation
- Requires IRB review and approval prior to study initiation
Nonsignificant Risk (NSR) Devices Approval Process:
- IDE submission and FDA approval is not required.
- Only requires IRB approval prior to study initiation.
If the sponsor (sponsor-investigator) believes it is a NSR study, the study can be be directly submitted to the IRB for review.
If the IRB agrees with the NSR assessment, the study is an abbreviated IDE and must must comply with abbreviated IDE requirements (21 CFR 812.2 (b)).
If the IRB disagrees with the sponsor-investigator’s NSR assessment, the sponsor (sponsor-investigator) must report this to the FDA within 5 working days (CFR 812.150(b)(9)).
The guidance “Significant Risk and Nonsignificant Risk Medical Device Studies” provides advice to sponsors, clinical investigators, and institutional review boards (IRBs) on how to determine the differences between significant risk and nonsignificant risk medical device studies. The FDA can make the study risk or IDE exempt determination and would be the final arbitrator.
The FDA slide deck “Is My Product a Medical Device” describes also this and more!