Definition
A medical device is defined as: “An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: 1) recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them; 2) 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 3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve 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 its primary intended purposes.”[1]
ENTERING THE US MEDICAL DEVICE MARKET
Before a company can market a new medical device, the manufacturer of the device must obtain FDA clearance to market the device in the form of a premarket clearance (also known as a Premarket Notification 510(k)) or Premarket Approval (PMA), unless the device is exempt from premarket approval. Medical devices are classified into Class I, Class II, and Class III devices. Most Class I devices are exempt from Premarket Notification 510(k). Most Class II devices require Premarket Notification 510(k). Most Class III devices require Premarket Approval. In addition, the sponsor or manufacturer must:
- Register as a manufacturer with the FDA
- List the medical device with the FDA
- Apply for an Investigational Device Exemption (IDE) for clinical studies (if necessary)
- Comply with Quality Systems (QS) regulations including Good Manufacturing Practices
- Comply with labeling regulations
- Comply with medical device reporting regulations[1]
DEVICE CLASSIFICATION
The first step in gaining market approval from the FDA is to classify the medical device. There are three classes of medical devices—Class I, Class II, and Class III. Examples of devices in each class are listed below:
- Class I Devices: Class I devices are subject to the least regulatory control, as they present minimal potential for harm to the user. Examples of Class I devices include items such as bandages, toothbrushes, and canes.
- Class II Devices: Most Class II devices require Premarket Notification 510(k). Examples of Class II devices include items such as tracheal tubes, dentures, blood pressure alarms, and certain types of pregnancy tests.
- Class III Devices: Most Class III devices require Premarket Approval. Examples of Class III devices include items such as drug eluting stents, atrial defibrillators, cochlear implants, fetal pulse oximeters, and pacemakers.[2]
The classification level of your device can be determined by searching the FDA’s Device Classification Panels. Alternatively, one can search the CDRH’s Product Classification Database.
Unless exempt under FDA regulations, devices are typically subject to one of two types of FDA premarket review before they may be legally marketed in the US:
- Premarket Approval (PMA): The manufacturer must provide evidence, typically including clinical data, providing reasonable assurance that the new device is safe and effective. The PMA process is the most stringent type of premarket review. A successful submission results in FDA clearance.
- Premarket Notification 510(k): The manufacturer must demonstrate to the FDA that the new device is substantially equivalent to a device already legally on the market that does not require a PMA. A successful submission results in FDA clearance.
In general, Class I and Class II devices, subject to premarket review, are required to obtain FDA clearance through the 510(k) process. Class III devices are required to obtain FDA approval through the more stringent PMA process.[3] [4]
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