FAQs About Consumer Medical Devices
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:
- Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them;
- Intended for use in the diagnosis of a disease or other condition, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals; or,
- Intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.
- How are Medical Devices Classified?
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.
- Class I – These are devices that present minimal potential for harm to the user. Examples include enema kits and elastic bandages. 35% of medical device types are Class I and 93% of these are exempt from pre-market review.
- Class II –These are devices that generally present a moderate risk of harm to the user. Examples of Class II devices include powered wheelchairs and some pregnancy test kits. 53% of device types are Class II, most of which require FDA review through premarket notification (510(k)).
- Class III – These are devices that sustain or support life, are implanted, or present potential high risk of illness or injury. Examples of Class III devices include implantable pacemakers and breast implants. 9% of device types are Class III and require FDA review through premarket approval (PMA) or humanitarian device exemption (HDE).
- Unclassified/Not classified – These are device types that FDA has not yet classified. 3% of device types are unclassified/not classified.
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.
- How are Medical Devices Regulated in the United States?
There are various processes that FDA use to review information about medical devices before they are allowed to be marketed in the United States:
- Premarket Notification [510(k)] – Submission required to demonstrate that the device is substantially equivalent to a device already placed into one of the three device classifications before it is marketed.
- Premarket Approval (PMA) – Application required to demonstrate that the device is safe and effective when used. It is the most stringent type of device marketing application and is required for Class III devices.
- Humanitarian Device Exemption (HDE) – A marketing application for a Humanitarian Use Device (HUD). An HUD is a medical device that is intended to benefit patients in the treatment or diagnosis of a disease or condition that affects, or is manifested in not more than 8,000 individuals in the United States per year.
- What is the difference between Cleared and Approved?
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.
- How do I report a problem with a Medical Device?
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.