FDA Medical Device Classification.The US Food and Drug Administration (FDA) classifies medical devices on the basis of the potential risk to the user. The FDA has established three classes of device, namely Class I – Low risk, Class II – Medium Risk, Class III – High Risk. Medical Device Classification is influenced by factors such as the intended purpose of the device, the location within the patient where the device will be applied, the duration of contact with the patient, will the device be active or passive.
Examples of Class I low risk devices, are bandages, medical gloves, crutches, wheelchairs, arm slings, tongue depressors, oxygen masks, powered toothbrushes.
Examples of Class II medium risk devices, are blood pressure monitors, surgical needles, surgical drapes, surgical lasers for dermatology, infusion pumps, X-ray machines, nebulizers.
Examples of Class III high risk devices, are heart pacemakers, intra-aortic balloons, silicone gel-filled breast implants, automated external defibrillators, intra-ocular lenses, HIV diagnostic kits, cardio-vascular stents.
FDA Medical Device Classification structure.The FDA has pre-determined approximately 1700 different generic types of medical devices. Each of these device types is allocated to 16 different medical panels. Each generic device is then assigned to one of the “Classes” (i.e. Class I, Class II, Class III) based on the potential patient risk associated with the device.
Class I devices which are “exempt” just need “General Controls”.
Class I devices, which are outside allowed “exemptions”, need “General and Special Controls”.
Class II devices which are substantially equivalent to a “predicate device” need “General and Special Controls”.
Class II devices which do not have an “equivalent predicate device” need “General and Special Controls” plus “Clinical data”.
Class III devices need “General and Special Controls” plus “Clinical data”.
Medical Device “approval requirements”.Class I devices need to be developed and manufactured per “general controls” such as having appropriate labelling, the device labelling or branding cannot be misleading, the manufacturing establishment must be registered with the FDA, effective manufacturing controls should be in-place and the FDA need to be informed of the product to be placed onto the market, however this is not a pre-market approval requirement. Note: “effective manufacturing controls” does not equate to a requirement to have established “good manufacturing practices”.
Class II devices, and Class I devices outside the allowed “exemptions” need to undergo the 510(K) clearance to market approval process. Class II devices require “special controls” which include labelling controls and post market surveillance. Class II devices should be manufactured in accordance with “good manufacturing practices”.
Class III devices will need to undergo the PMA (pre-market approval) process. Note: There are some exemptions from full PMA approval, for example if the device is substantially equivalent to a device which was on the market prior to 1976 and a PMA was not previously required.
FDA Medical Device Classification is based on the “Intended use”.The “intended use” as defined in the “indications for use” will strongly influence the risk classification of the device. Some medical devices may have a range of potential uses. If a device is placed on the market with a specific “indication for use”, it is that use which determines classification. Note: a device cannot be classified per a low risk use, then marketed for a higher risk application. In such a situation, the device would need to be re-classified and undergo the appropriate approval process.
Medical Devices and Pre-market Notification 510(k).Class I and Class II devices need to undergo a 510(K) approval unless “exempt”. The majority of class I devices will be exempt. A 510(k) is a submission made to the FDA which details that a device to be placed onto the US market, is substantially equivalent to a device already on the market which has not been subject to PMA requirements. The 510(K) process is significantly less onerous than the PMA process, therefore there is a benefit in identifying if an equivalent device already exists.
How to determine Medical Device Classification.To confirm a medical device classification, in addition to understanding what if any exemptions exist, the applicable device regulation number needs to be identified. The FDA maintains a device classification database and it is possible to find the applicable regulations either via identifying the appropriate “panel” or equivalent device.
The classification “panels” in the FDA CFR detail a list of devices within that “panel”. When a device is identified per the panel lists, then the appropriate classification is detailed. Each classified device has a 7-digit number associated with it. Once you find your device in the panel’s beginning list, go to the section indicated. It describes the device and says it is, for example Class II.
Some Class I devices are exempt from the premarket notification and/or parts of the good manufacturing practices regulations. Approximately 74% of the Class I devices are exempt from the premarket notification process. These exemptions are listed in the classification regulations of 21 CFR and also have been collected together in the Medical Device Exemptions document.
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FDA Device classification database: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm
FDA Medical Device Panels: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051530.htm
FDA Medical Device Exemptions: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm