The FDA has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes (Class I, Class II and Class III) based on the level of control necessary to assure the safety and effectiveness of the device. The device classification defines the regulatory requirements for an approval of a new device. Regulatory control increases from Class I to Class II to Class III. Device classification depends on the intended use of the device and also upon indications for use. In addition, classification is risk based, that is, the risk the device poses to the patient and/or the user is a major factor in the class it is assigned.
Examples:
Class I devices: elastic bandages, examination gloves, and hand-held surgical instruments.
Class II devices: powered wheelchairs, infusion pumps, and surgical drapes.
Class III devices: implantable pacemaker pulse generators and coronary stents.
To find the classification of a device, as well as whether any exemptions may exist, the classification regulation number should be determined for the device. One of the ways to accomplish this is to go directly to the FDA classification database and search for a part of the device name. Once the correct classification regulation has been identified, go to the device panel (medical specialty) to which the device belongs. The search will provide the Device Classification and the appropriate CFR regulation for the device. If the device is not classified, similar devices can be researched on the FDA website (PMA and 510(k) databases) or pre-IDE consultation can be used for the FDA determination.
The Office for Research Protections Quality Assurance Program can help investigators determine if their research involves testing a FDA-regulated medical device. Contact them at orp-qm@psu.edu.