Table of Contents
What are the different types of medical devices?
There are 3 classes of medical devices:
- Class I devices are low-risk devices. Examples include bandages, handheld surgical instruments, and nonelectric wheelchairs.
- Class II devices are intermediate-risk devices.
- Class III devices are high-risk devices that are very important to health or sustaining life.
How many classifications are there for medical devices?
three classes
Classification of Medical Devices 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 safety and effectiveness.
How many different types of medical devices are regulated by the FDA?
1,700 distinct types
The FDA has classified over 1,700 distinct types of medical devices. The devices are organized in the Code of Federal Regulations (CFR) according to 16 specialties, such as cardiovascular or hematology devices.
What are Class A medical devices?
LIST OF MEDICAL DEVICES ALONG WITH THEIR RISK CLASS
| S.No | Notified Device Category/Drug | Risk Class |
|---|---|---|
| 1 | Catheters | Class A |
| 2 | Disposable Perfusion Sets | Class A |
| 3 | Surgical Dressings | Class A |
| 4 | Surgical Dressings | Class A |
What are some examples of Class 1 medical devices?
Approximately 47\% of medical devices are considered a class I medical device, 95\% of which are exempt from the regulatory process. Examples of class I medical devices include elastic bandages, examination gloves, electric toothbrushes, hospital beds and hand-held surgical instruments, to name a few.
What is a Class C medical device?
Devices are classified as class C for blood grouping or tissue typing to ensure immunological compatibility of blood, blood components, cells, tissues or organs intended for transfusion, transplantation or cell administration.
What is a Class 2 device?
Class II medical devices are those devices that have a moderate to high risk to the patient and/or user. 43\% of medical devices fall under this category. Most medical devices are considered Class II devices. Examples of Class II devices include powered wheelchairs and some pregnancy test kits.