When does your medical device testing need IRB approval?

Medical Device studies need Investigational Device Exemption (IDE) determination from an Institutional Review Board (IRB) when:
• Data is being collected on safety and effectiveness regardless of whether or not the results are intended for FDA submission
• New disease or condition
• New intended use
• New patient population
• Significant design changes
• Significant use changes

HOWever, SOME MEDICAL DEVICE USAGE IS EXEMPT FROM

21 CFR PART 812 (IDE):

Medical Device Sponsors and Clinical Investigators may be exempt from 21 CFR Part 812 regulations regarding Investigational Device Exemption (IDE) requirements (meaning that they need neither FDA nor Institutional Review Board (IRB) approval) if the medical device is:

• used in accordance with its legally marketed labeling,

• testing only consumer preference (i.e., no safety or efficacy tests),

• testing a modification that:

(1) is not for the purpose of determining safety or efficacy and

(2) does not put subjects at risk,

• intended solely for veterinary use, or

• a diagnostic that:

• complies with 809.10(c) labeling requirements and

• the testing

• is noninvasive;

• does not pose a significant risk;

• does not introduce energy into a subject; and is not used as a diagnostic procedure without confirmation by another medically established diagnostic product or procedure

Doing a Medical Device Clinical Trial?....Know Your Device's Risk Significance

When submitting your medical device clinical trial documents to an Institutional Review Board (IRB), you must know if your device is considered Significant Risk (SR) or Non-Significant Risk (NSR).

Significant Risk (SR) devices pose potential for serious risk to the health, safety, or welfare of a subject

Non-Significant Risk (NSR) devices are defined as those not being categorized as significant risk (SR)


This determination is important:
SR devices require both IRB and FDA approval before starting a clinical trial
NSR devices require only IRB approval before starting a clinical trial

Yes, that's right that you can initiate a medical device clinical trial without notifying the FDA if your medical device is a Non-Significant Risk device and you obtain IRB approval for your study.  That's a big difference from pharma studies where all drugs are considered high risk and require FDA approval before beginning a drug clinical trial.

So what defines an SR device?...

Under US regulation 21 CFR 812.3(m), an SR device means an investigational device that:

• Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;
• Is purported or represented to be for use supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject;
• Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or
• Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.

The definition of NSR is by default.  Your device is Non-Significant Risk (NSR) if your device does not meet the above definition for an SR device.

But who makes the final decision on SR versus NSR categorization?

Your Institutional Review Board (IRB) does (21 CFR 812.66)

If you want to start a clinical trial and you feel that your device does not pose a significant risk to study subjects:

• You (the Sponsor) submit your clinical trial documents (e.g., protocol, device description, Informed Consent Form, etc.) to your IRB along with a statement of why your device trial does not pose a significant risk to study subjects

• If the IRB agrees that the clinical trial does not pose a significant risk and determines the trial device as an NSR, then, no FDA approval is needed before you start the trial. Your clinical trial can start under AbbreviatedInvestigational Device Exemption(Abbreviated IDE) requirements.

• If the IRB disagrees and they deem your trial to pose a significant risk, then your device is deemed SR and you must submit an Investigational Device Exemption (IDE) application to FDA for approval before starting your trial.

So if you are planning to start a medical device clinical trial, you need to know your risk significance (SR or NSR).  Note that this is different from your risk classification, which in the US, medical devices are also classified according to their risk (Class I devices are lowest risk; Class II devices are medium risk; Class III devices are highest risk).

It can be confusing to know how to distinguish risk classification from risk significance, but think of it this way:

• your medical device's risk classification is determined by the FDA according to your device's level of risk (Class I, II, or III) regardless of whether you are planning a clinical trial or not.
• when initiating a clinical trial, your IRB will assess the device's risk significance (SR or NSR) and that will determine if you need to go to the FDA and apply for an Investigational Device Exemption (IDE) before you can receive IRB approval for your clinical trial. If your IRB deems your device to be SR, then you will need to apply for an IDE from the FDA (got to love all those acronyms).

What is a medical device?

The US government has a definition of what a medical device is and this is important to know when your product meets this definition because if it does, you will need to comply with the US medical device regulations.  The definition below is for the United States, but there are similar definitions for European, Asian, and other North/South American countries.

Section 201(h) of the US Federal Food Drug & Cosmetic (FD&C) Act regulated by the Food and Drug Administration (FDA) defines a medical device as:

• an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

• recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,

• intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

• intended to affect the structure or any function of the body of man or other animals, and

• which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term "device" does not include software functions excluded pursuant to section 520(o).

So what are some key takeaways from the above definition?

•  The definition clearly goes out of its way to capture a broad set of terms that could be used to describe a medical device (e.g., implement, machine, contrivance, etc.)
•  Note that the definition includes both "treatment" devices such as those that come in contact with the body (ex. an artificial hip) and "diagnostic" devices that do not contact the body such as a lab test that is used to determine if a person has a disease or not.
•  The definition applies for both human and veterinary medicine
•  The last bullet paragraph is what really distinguishes "medical device" from "drug/pharmaceutical" by stating that the primary intended purpose is not achieved through chemical action.