Medical Products Classification

Classify Your Medical Device | FDA

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

The three classes and the requirements which apply to them are: Device Class and Regulatory Controls 1. Class I General Controls With Exemptions Without Exemptions 2. Class II General Controls and...

Products and Medical Procedures | FDA

https://www.fda.gov/medical-devices/products-and-medical-procedures

Our Medical Device Product Classification database lists over 6,000 types of medical devices regulated by FDA's Center for Medical Devices and Radiological …

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 …

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 …

Product Classification - Food and Drug Administration

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/PCDSimpleSearch.cfm

Medical Device Classification (FDA & EU MDR)

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

The US FDA’s classification of a medical device is based on its risk. Low and moderate-risk devices are classified as either Class I or Class II medical devices. …

Product Classification in Healthcare - GS1

https://www.gs1.org/sites/default/files/docs/healthcare/product_classification_in_healthcare.pdf

Classification –A form of cataloguing, or identifying, products and can be defined as a process for grouping products into categories based on an understanding of the …

Health products policy and standards - World Health …

https://www.who.int/teams/health-product-policy-and-standards/assistive-and-medical-technology/medical-devices/nomenclature

Some types of medical devices include: single use devices (i.e. syringes, catheters) implantable (i.e. hip prothesis, pacemakers) imaging (i.e. ultrasound and CT scanners) …

Classification of Products as Drugs and Devices and …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/classification-products-drugs-and-devices-and-additional-product-classification-issues

Classification of Products as Drugs and Devices and Additional Product Classification Issues ...

Drug Classes and Medication Classification

https://www.verywellhealth.com/drug-classes-1123991

In 1976, the World Health Organization (WHO) created a system called the Anatomical Therapeutic Chemical (ATC) Classification System. It categorizes a …