Determining Medical Device Classifications

Classify Your Medical Device | FDA

https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device

Each classification panel in the CFR begins with a list of devices classified in that panel. Each classified device has a 7-digit number associated with it, e.g., 21 CFR 880.2920 - Clinical...

How to Determine if Your Product is a Medical Device | FDA

https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device

Overview of Medical Device Classification and …

https://www.fda.gov/about-fda/cdrh-transparency/overview-medical-device-classification-and-reclassification

The FDA categorizes medical devices into one of three classes – Class I, II, or III – based on their risks and the regulatory controls necessary to provide a reasonable assurance of …

Medical Device Classification (FDA & EU MDR)

https://www.simplerqms.com/medical-device-classification/

Other ways to determine your medical device class in the US are the following: You can use a free, confidential, and informal device determination service via email: …

How is My Medical Device Classified? - Food and …

https://www.fda.gov/media/131270/download

Classes of Medical Devices ClassRisk Potential HarmRegulatory ControlsSubmission Type orExemption I Lowest II Moderate HighestPresent minimal …

The Ultimate Guide to Medical Device Classification - US FDA

https://essenvia.com/blog/regulatory-operations/the-ultimate-guide-to-medical-device-classification-for-us-fda-eu-medical-device-regulation-mdr

An EU medical device classification is necessary before obtaining a CE marking. The essential information for determining a medical device’s class is available …

Medical Device Classification Guide - How …

https://www.greenlight.guru/blog/medical-device-regulatory-classification

There are four levels of medical device classifications in Canada: Class I; Class II; Class III; Class IV; Prior to going to market in Canada, you must first …

Product Code Classification Database | FDA

https://www.fda.gov/medical-devices/classify-your-medical-device/product-code-classification-database

The Product Classification Database contains medical device names and associated information developed by the Center for Devices and Radiological Health (CDRH) in …

How to Determine Your Medical Device's …

https://www.mindflowdesign.com/insights/medical-devices-fda-classification-process/

The FDA recognizes three categories of medical devices: Classes I, II, and III. The difference between each class has to do with a product’s intended …

Classification of Medical Devices according to MDD

https://www.johner-institute.com/articles/regulatory-affairs/classification/

The Medical Device Directive lists the classification rules in Appendix IX, which states that the medical products fall into one of the following classifications: Class I Class I *, …