3 Systems of Risk for Medical Devices from FDA

Why does the FDA have three systems in place to address and handle risk related to medical devices? Each system serves a different purpose, but are all three actually necessary?

In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about FDA’s three systems of risk for medical devices and the unique interdependencies and distinctions between them.

Some highlights of this episode include:

Three systems for medical device risk from FDA: product classification, significant vs. nonsignificant risk, software level of concern.
The FDA’s classification system handles risk by classifying medical devices as Class I, II, or III. The higher the class, the higher the risk. The lower the class, the lower the risk. Yet, risk is a broad subject and there are a ton of exceptions.
Also, classification numbers/levels used by the FDA in the United States do not translate in a linear way to those in the European Union (EU) and elsewhere. There are similar systems but different rules that are philosophically different.
The significant vs. nonsignificant risk system focuses on clinical trials for medical devices. All clinical evaluations of investigational devices, unless exempt, must have an approved investigational device exemption (IDE).
The software level of concern is important because it determines the level of documentation required for software development.
The default classification for any new medical device is Class III. If it’s a new device, it’s not well-established and the benefits and risks are relatively unknown.
When it comes to labeling, say anything as long as you can prove and support it. When technology stays the same but the labeling claim changes, risk changes.
The determination of significant or nonsignificant risk is not made by the FDA or Institutional Review Board (IRB), but the medical device company.
The software level of concern consists of Class a, b, and c. Does the software have no possibility of causing injury or damage to health? Is non-serious injury possible? Or, is serious injury or death possible?

Memorable quotes by Mike Drues:

“Theoretically, the classification of your medical device depends on risk. In other words, the higher the class, the higher the risk. The lower the class, the lower the risk.”

“The default classification for any new medical device is Class III, which basically means we set the bar at the highest possible level.”

“Oftentimes in regulation, we do things not because they make sense, but because that’s the way we’ve done them in the past.”

“The determination of significant or nonsignificant risk is not up to the FDA. It’s not even up to your IRB, or Institutional Review Board, it’s up to the company.”