Oct 8, 2021
What is a Medical Device
A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is:
The FDA regulates a wide range of medical devices, including, pacemakers, cardiovascular stents, respiratory ventilators, breast implants, diagnostic tests (pregnancy tests, blood glucose tests, etc.) and relatively simple devices such as tongue depressors, patient scales, and elastic bandages.
Medical devices are classified based on the risks associated with the use of the device. Devices are classified as Class I, Class II, or Class III — with Class I being the lowest risk and Class III the highest risk.
Some devices may be considered “exempt”. If a device is considered “exempt”, the manufacturer would not be required to submit a premarket notification submission [510 (k) submission] and obtain FDA clearance before marketing the device in the U.S. Examples of exempt devices include Class I devices and some Class II devices such as manual stethoscopes, mercury thermometers, AC-powered adjustable hospital beds, powered heating pads, and bedpans. However, the manufacturer is required to register their establishment and list their devices with the FDA.
There are various processes that FDA use to review information about medical devices before they are allowed to be marketed in the United States:
In order for medical devices to be legally marketed (sold) in the United States, they are required to be cleared or approved by FDA unless it is 510(k) exempt.
Cleared medical devices: These medical devices are ones that FDA has determined to be substantially equivalent to (similar) another legally marketed device. A premarket notification submission is referred to as a 510(k) and must be submitted to FDA to review and provide clearance.
Approved medical devices: Approved medical devices are those devices that FDA has approved a premarket approval (PMA) application or a Humanitarian Device Exemption (HDE) application. This review and approval process is for Class III medical devices (the ones with the highest risk) and involves a more rigorous review than the 510(k) review process.
You are encouraged to file a voluntary report by phone at 1.800.332.1088 or online at MedWatch, the FDA Safety Information and Adverse Event Reporting program if you have experienced a problem with a medical device.
You may also wish to report adverse reactions or other problems with FDA-regulated products. To do so, contact the FDA Consumer Complaint Coordinator for the state in which you reside. Learn more here.