Classify Your Medical Device | FDA
The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as...
FDA Medical Device Classification: Class I, II, III Explained (2025)
Jul 15, 2025 · Complete guide to FDA device classes I, II & III. Learn classification criteria, regulatory pathways, examples & requirements for 2025.
The 3 FDA medical device classes: differences and examples ... - Qualio
Jan 14, 2025 · Learn about the 3 FDA medical device classes. We give comprehensive definitions, examples, and differences of Class I, II, and III devices.
Class I vs Class II vs Class III Medical Devices: Classification Guide
Jun 18, 2025 · Medical devices are regulated by the U.S. Food and Drug Administration (FDA). Each device must meet rules based on its risk to users. These rules fall into three levels: Class I, Class II, …
21 CFR Part 860 -- Medical Device Classification Procedures
Classification regulation means a section under parts 862 through 892 of this chapter that contains the identification (general description and intended use) and classification (class I, II or III) of a single …
A Complete Guide to Classifying Your Medical Device for FDA Approval
Jan 23, 2025 · When bringing a new medical device to market in the United States, one of the first—and most critical—steps is determining its classification. This step is crucial because it dictates the …
Class I and Class II Device Exemptions | FDA
Jul 1, 2025 · To determine whether a device is exempt from 510 (k) or GMP requirements, search the FDA’s Product Classification database. Most class I and some class II devices are exempt from 510 …
Medical Device Classification - Overview of 3 Classes | Gilero
Apr 18, 2025 · Product classification determines the regulatory rules and requirements you must comply with before you can sell your product. Each class has their own set of regulations, and knowing the …
FDA Medical Device Classification: Classes, Examples
Jan 22, 2024 · Medical device classes are a tiered categorization scheme based on potential risks to patients. Class I medical devices present the lowest risk with minimal potential for harm. Class II …
Medical Device Classifications: Determine Your Device Class
Apr 2, 2024 · In this guide, I will provide you with a step-by-step approach to determining how your medical device will be classified by U.S. FDA, the European Commission, and Health Canada. …