Medical devices
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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 disease or other conditions, 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.
as defined by the US Food and Drug Administration.
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Classifications
According to the FDA, there are three classes of medical devices. The classification of a medical device depends upon intended use and indications for use. The classification procedures can be found in 21 CFR 860 document.
Class I: General Controls
These devices are subject to general controls which are those controls that are sufficient to provide reasonable assurance of the safety and effectiveness of the device, or the device is not life-supporting or life-sustaining and does not present a reasonable source of injury through normal usage. Devices in this category include tongue depressors, bedpans, and other similar types of common equipment.
Class II: General Controls with Special Controls
A Class II device is, or may be in the future, subject to special controls that ensure the safety and efficacy of the device. Devices in class II are held to a higher level of assurance that they will perform as indicated and will not cause injury or harm to patient or user. They may be subject to clinical trials and 510(k) submission prior to release for general use. Devices in this class are typically non-invasive and include x-ray machines, PACS, and other modalities.
Class III: General Controls and Premarket Approval
A Class III device needs to go through premarket approval (PMA) by the FDA before it can be marketed for use. Class II devices are usually invasive, life-sustaining, life-supporting, or is used "in preventing impairment of human health or if the device presents a potential unreasonable risk of illness or injury".
References
- Device Advice - Is the Product a Medical Device
- Title 21 Food and Drugs Subchapter-H Medical Devices
Medical device companies
Related topics
External links
- [1] - US Food and Drug Administration - Center for Devices and Radiological Health
- [2] - Medical Devices Blog
- [3] - Medical Devices Manufacturers' Association