---
title: "Regulatory Pathways - Medical Device Brochure"
type: white-paper
publisher: Ketryx
source: "https://www.ketryx.com/assets/regulatory-pathways"
content: text extracted from PDF (layout/tables/figures not preserved)
---

# Regulatory Pathways - Medical Device Brochure

*Source: [https://www.ketryx.com/assets/regulatory-pathways](https://www.ketryx.com/assets/regulatory-pathways)*

---

Introduction When it comes to medical device regulations, a lot of terminology exists: device classes, regulatory approval pathways, and many others. We made this brochure to help you understand the possible pathways to create a medical device. Predicate Device In the United States, a Predicate Device is a legal market device that is substantially equivalent to the device in question. That is, a Predicate Device is an existing device already approved by the Federal Drug Administration (FDA) that is similar to your device. Device Classification The first thing you need to know is the possible classification of your device. If a Predicate Device exists in the market already, and you know what it is, then this process becomes much simpler. If not, you can use our Predicate Device Search tool to find possible predicate devices. The FDA has three device classifications: I, II, and III. The details for each class follow. Class I This class covers low-risk devices, like bandages and scalpels. Many of these devices require only registration, not FDA approval, unless they use software. Class II Class II includes moderate-risk devices that could cause non-serious injury. These devices require approval by the FDA, most commonly through a 510(k) or De Novo pathway.1 Class III This class includes high-risk devices that could cause serious injury or death. Examples include implantable heart monitors and cochlear implants, among many others. Class III devices require pre-market approval (PMA) by the FDA. This category prevents consumers from exposure to dangerous devices by requiring testing and approval before marketing. 1 See info about “De Novo” pathways; https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request

Several other categories deserve attention 510(k) This category requires proof that the device is substantially equivalent (SE) to a legally marketed device that is not subject to PMA. De Novo This category applies to device “types” that have never been marketed in the United States but whose safety profile and technology are now reasonably well understood. Pre-Market Approval (PMA) Class III devices require this regulatory pathway. It requires the device manufacturers to prove to the FDA that the device is both safe and effective. This pathway ensures that consumers do not buy devices that are unsafe and ineffective; it guarantees that devices have proven value.