FDA Medical Device Classification
FDA Medical Device Classification is different from the EU MDR classification. The classification method and criteria also differ. FDA 510k device classification depends on the intended use and indications of the use of the device.
The US FDA has established classifications for approximately 1700 different generic types of devices and categorized them into 17 medical specialties. Each of these generic types of devices is assigned to one of the three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. Classifying the device in scope according to one of these specialties (I, II or III) is the first step in deciding the regulatory compliance route.
FDA Medical Device Classification Specialties
Anesthesiology, Cardiovascular, Chemistry, Dental, Ear, nose and throat, Gastroenterology and urology, General and plastic surgery, General hospital, Hematology, Immunology, Microbiology, Neurology, Obstetrical and gynecological, Ophthalmic, Orthopedic, Pathology, Physical medicine, Radiology, Toxicology
FDA Classification of Class I - Low Risk (General Controls)
Devices are subjected to a comprehensive set of regulatory authorities called general controls that are applicable to all classes of devices.
- Reusable surgical Instruments
- Hospital Furnitures
- OT equipments
FDA Classification of Class II - Moderate Risk (General & Special Controls)
Devices for which general controls, by themselves, are insufficient to provide reasonable assurance of safety and effectiveness of the device, and for which there is sufficient information to establish special controls to provide such assurance.
- Urology Catheters
- Patient Monitors
FDA Classification of Class III - High Risk (General Controls & PMA)
Devices for which general controls, by themselves, are insufficient and for which there is insufficient information to establish special controls to provide reasonable assurance of safety and effectiveness of the device. Class III devices typically require pre-market approval (PMA).
- PTCA Catheters
- Heart Valves
Intended use and indications for use.
FDA Medical Device Classification is based on the intended use and indications for use. The difference between these terminologies is explained below.
- Intended Use is the general purpose of the medical device or use as per the manufacturer instruction for use or claim.
- Indications for Use disease or condition the medical device will diagnose, treat, prevent, cure, or mitigate, including a description of the target patient population.
The intended use, Indications for use, Description, Mechanism and final specification all will play a major in the device classification.
If your product is found to be “exempt,” just general regulations apply, and no formal FDA submission is necessary. You must, however, register your business with the FDA and then list the product.
If you discover that your product requires specific controls, you will need to prepare a 510(k) filing to the FDA and obtain clearance before coming to market. Following that, you must register your business and list the product.
If your product requires premarket approval, you must follow the FDA PMA process to obtain permission before going to market.